ISO/FDIS 10477

Dentistry — Polymer-based crown and veneering materials

Médecine bucco-dentaire — Produits à base de polymères pour couronnes et facettes

General Information

• Status: Not Published
• ICS: 11.060.10 - Dental materials
• Technical Committee: ISO/TC 106/SC 2 - Prosthodontic materials
• Drafting Committee: ISO/TC 106/SC 2 - Prosthodontic materials
• Current Stage: 5000 - FDIS registered for formal approval
• Start Date: 02-Feb-2026
• Completion Date: 22-Sep-2025

Relations

• Consolidates: prEN ISO 10477 - Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
• Effective Date: 12-Feb-2026
• Consolidates: ISO 15708-4:2017 - Non-destructive testing — Radiation methods for computed tomography — Part 4: Qualification
• Effective Date: 19-Nov-2022
• Revises: ISO 10477:2020 - Dentistry — Polymer-based crown and veneering materials
• Effective Date: 06-Jun-2022

Overview

ISO/FDIS 10477: Dentistry - Polymer-based crown and veneering materials is an international standard developed by ISO/TC 106/SC 2 that specifies requirements and classification for polymer-based materials used in the fabrication of dental crowns and veneers. This standard enhances the quality, safety, and effectiveness of permanent laboratory-fabricated restorative dental materials, contributing to improved patient outcomes and consistency in dental practice worldwide.

By providing clear test methods and performance criteria, ISO 10477 supports manufacturers, dental technicians, and regulatory bodies in evaluating and verifying polymer-based crown and veneering materials for clinical use. The standard addresses key properties such as physical strength, chemical stability, shade consistency, and proper labeling, ensuring these dental materials meet the needs of dental professionals and patients alike.

Key Topics

• Material Classification: ISO 10477 classifies polymer-based crown and veneering materials by the type of curing or manufacturing process they undergo. Types and classes address self-curing, external-energy-curing, dual-curing, 3D printing (additive manufacturing), and milling (subtractive manufacturing).
• Product Requirements: The standard defines mandatory properties and performance thresholds, including:
  • Depth of cure
  • Surface finish quality (glossy appearance)
  • Flexural strength (minimum defined MPa values)
  • Bond strength to substructure (≥5 MPa or higher as claimed)
  • Water sorption and solubility limits
  • Shade consistency and colour stability across batches
• Testing Methods: ISO 10477 sets out specific procedures for specimen preparation and testing conditions, such as visual inspection, flexural strength measurement, and shade comparison, ensuring reliable and reproducible assessment of material properties.
• Packaging and Labeling: Guidance is given on appropriate packaging, labeling, and instructions for use, supporting safe handling and accurate communication from manufacturers to end users.

Applications

ISO/FDIS 10477 is highly relevant in several areas of dental practice and dental product manufacturing:

• Manufacturers of Dental Materials: Assists in the development and quality control of polymer-based materials for crowns and veneers, ensuring conformity with international standards before distribution.
• Dental Technicians and Laboratories: Provides guidelines for selecting appropriate materials based on type (self-curing, light-curing, printed, milled), and assessing their performance, leading to improved laboratory-fabricated dental restorations.
• Regulatory Bodies: Offers a harmonized reference point for regulatory compliance and product approval in dental healthcare markets.
• Dentists and Clinicians: Informs professionals about the performance characteristics and limitations of polymer-based restorative materials, supporting evidence-based clinical decisions and enhanced patient safety.

Related Standards

Several international standards provide complementary guidance and definitions relevant to ISO 10477, including:

• ISO 1942: Dentistry - Vocabulary
• ISO 7491: Dental materials - Determination of colour stability
• ISO 3696: Water for analytical laboratory use - Specification and test methods
• ISO 6507-1: Metallic materials - Vickers hardness test
• ISO 6344: Coated abrasives - Grain size distribution
• ISO 7405: Dentistry - Evaluation of biocompatibility of medical devices
• ISO 18739: Process chain for CAD/CAM systems in dentistry
• ISO 5139: Polymer-based composite machinable blanks
• ISO/ASTM 52900: Additive manufacturing - General principles

Referencing ISO/FDIS 10477, together with related standards, establishes a robust framework for product development, assessment, and regulatory compliance surrounding polymer-based dental restorations. This standard is essential for advancing quality assurance and international harmonization in restorative dentistry.

Standards Content (Sample)

DRAFT
International
Standard
ISO/DIS 10477
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour
2025-03-10
couronnes et facettes
Voting terminates on:
ICS: 11.060.10 2025-06-02
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 10477:2025(en)
DRAFT
ISO/DIS 10477:2025(en)
International
Standard
ISO/DIS 10477
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Voting terminates on:
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 10477:2025(en)
ii
ISO/DIS 10477:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 General .3
5.2 Depth of cure .3
5.2.1 General .3
5.2.2 Depth of cure (only type 2 class 2 materials) .4
5.3 Surface finish .4
5.4 Flexural strength.4
5.5 Bond strength .4
5.5.1 Special bonding system without macromechanical retention .4
5.5.2 Values higher than 5 MPa .4
5.6 Water sorption .4
5.7 Solubility .5
5.8 Shade consistency .5
5.9 Colour stability .5
6 Sampling . 5
6.1 For all tests.5
6.2 For test of shade consistency .5
6.3 For test of colour stability .5
7 Measurement and test methods . 5
7.1 General .5
7.1.1 Ambient test conditions .5
7.1.2 Water .6
7.1.3 Preparation of test specimens .6
7.2 Visual inspection .6
7.3 Depth of cure (only for type 2, class 2 if not opaque resin) .6
7.3.1 Apparatus .6
7.3.2 Materials .6
7.3.3 Procedure .7
7.3.4 Expression of results .7
7.4 Surface finish .7
7.4.1 Apparatus (for type 2 class 3 and type 4 materials) .7
7.4.2 Specimen preparation .7
7.4.3 Surface polishing .8
7.5 Flexural strength.9
7.5.1 Apparatus .9
7.5.2 Materials .10
7.5.3 Preparation of test specimens .11
7.5.4 Procedure . 12
7.5.5 Expression of results . 12
7.6 Bond strength (only type 1, type 2 classes 1 and 2, and type 3 materials), . 13
7.6.1 Apparatus . 13
7.6.2 Materials . 13
7.6.3 Preparation of test specimens . 13
7.6.4 Procedure .14
7.6.5 Expression of results . 15
7.7 Water sorption and solubility . 15

iii
ISO/DIS 10477:2025(en)
7.7.1 Apparatus . 15
7.7.2 Materials .16
7.7.3 Preparation of test specimen .16
7.7.4 Procedure .17
7.7.5 Expression of results .17
7.8 Shade consistency and colour stability .18
7.8.1 General .18
7.8.2 Apparatus .19
7.8.3 Materials .19
7.8.4 Preparation of test specimens .19
7.8.5 Procedure . 20
7.8.6 Colour comparison. 20
7.8.7 Expression of results for shade consistency . . 20
7.8.8 Expression of results for colour stability . 20
8 Packaging and labelling .21
8.1 Packaging .21
8.2 Labeling and instructions for use .21
Bibliography .24

iv
ISO/DIS 10477:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 10477:2020), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— addition of printed materials in Clause 4 as Type 2 Class 3;
— addition of milled materials in Clause 4 as Type 4.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 10477:2025(en)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
hazards are not included in this document, but it is recommended that, for the assessment of possible
biological hazards, reference should be made to ISO 10993-1 and ISO 7405.

vi
DRAFT International Standard ISO/DIS 10477:2025(en)
Dentistry — Polymer-based crown and veneering materials
1 Scope
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their
requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for
which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as
beads or wires.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 6344-2, Coated abrasives — Determination and designation of grain size distribution — Part 2: Macrogrit
sizes P12 to P220
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3: Microgrit
sizes P240 to P5000
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 18739, Dentistry — Vocabulary of process chain for CAD/CAM systems
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
ISO/ASTM 52900:2021, Additive manufacturing — General principles — Fundamentals and vocabulary
ISO 5139, Dentistry — Polymer-based composite machinable blanks
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

ISO/DIS 10477:2025(en)
3.1
polymer-based crown and veneering material
composition of powders, liquids, pastes (after full polymerization) or polymerized discs or blocks (already
polymerized by the manufacturer) that may contain monomers, inorganic and/or polymeric fillers suitable
for use as permanent dental veneers or crowns
Note 1 to entry: Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/or by
external energy activation [by heat (“heat-curing” materials), photoactivated materials, by visible light (“light-curing”
materials) and/or by UV radiation].
Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or
crowns may or may not be attached to a substructure.
3.2
dentine resin
pigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates the
natural appearance of dentine
3.3
enamel resin
translucent and slightly pigmented polymer-based crown and veneering material (3.1) that simulates the
natural appearance of enamel
3.4
cervical resin
intensely pigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates
the natural appearance of dentine of the cervical region of the tooth
3.5
opaque resin
intensely pigmented polymer-based crown and veneering material (3.1) applied in thin layers with the
purposes of completely masking the underlying material and bonding to it
Note 1 to entry: Opaque resins are only required to fulfil the requirement of 5.5.
3.6
milling
synonym subtractive manufacturing: process of machining, grinding, or reducing a larger bulk object to
create a smaller detailed three-dimensional object using CAD/CAM methods
Note 1 to entry: The term milling is used in this document as it is a common term in dental technology and clinical
dentistry for the processing of these materials
3.7
printing
synonym additive manufacturing: process in which a liquid photopolymer in a vat (3.8) is selectively cured
by light-activated polymerization. The liquid photopolymer may contain fillers.
Note 1 to entry: The term printing is used in this document as it is a common term in dental technology and clinical
dentistry for the processing of these materials
3.8
vat
small tub, part of the polymerization device that contains the liquid photopolymer.
4 Classification
The polymer-based crown and veneering materials described in this document shall be classified according
to their activation system for polymerization.
— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing initiator(s)
and activator(s) (“self-curing” materials);

ISO/DIS 10477:2025(en)
— Type 2: polymer-based crown and veneering materials whose setting is effected by the application of
energy from an external source (“external-energy-activated” materials), such as heat and/or radiation
(visible or UV range);
— Class 1: polymer-based crown and veneering materials that do not contain a photo-polymerization
initiator;
— Class 2: polymer-based crown and veneering materials that contain a photo-polymerization initiator
and are not intended for additive manufacturing (printing);
— Class 3: polymer-based crown and veneering materials that are intended for additive manufacturing
(printing);
— Type 3: polymer-based crown and veneering materials whose setting is affected by mixing initiator(s)
and activator(s) and also by the application of energy from an external source (“dual-cure” materials);
— Type 4: polymer-based crown and veneering materials that are intended for subtractive manufacturing
(milling).
5 Requirements
5.1 General
The tests required for a crown and veneering material depend on the classification according to type and class.
See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.
Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3 Type 4
Class 1 Class 2 Class 3
a b
5.2 Depth of cure — — + — — —
a a a a
5.3 Surface finish + + + + + +
a a a a
5.4 Flexural strength + + + + + +
c c
5.5 Bond strength to the + + + - + -
framework
a a a a
5.6 to 5.9 Water sorption, + + + + + +
solubility, shade
consistency, colour
stability
Key
+ carry out test;
— do not test;
a
If the material is opaque resin, do not test;
b
Not required because fixed part of the printing process;
c
Not required as these materials are not intended for veneering.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.

ISO/DIS 10477:2025(en)
5.2.2 Depth of cure (only type 2 class 2 materials)
For type 2 class 2 materials, the hardness of the bottom surface shall be not less than 70 % of that of the top
surface (see Table 2).
For type 1, type 2 class 1, and type 3 and type 4 materials, no requirement is specified. This requirement is
not applicable to opaque resins.
For type 2 class 3 materials no requirement is specified as the curing process is inherently defined in the
printing process.
5.3 Surface finish
A test specimen polished in accordance with 7.4 shall have a glossy surface.
Testing shall be carried out in accordance with 7.4. This requirement is not applicable to opaque resins.
5.4 Flexural strength
Flexural strength shall be at least 50 MPa for type 1 and type 2 classes 1 and 2 and type 3, and at least 80 MPa
for type 2 class 3 and type 4 materials (see Table 2). This requirement is not applicable to opaque resins.
Testing shall be carried out in accordance with 7.5.
Table 2 — Physical and chemical requirements
Subclause Property Requirement
5.2 Depth of cure Hardness of bottom surface ≥70 % of top surface
Flexural strength ≥50 MPa for type 1 and type 2 classes 1 and 2
5.4 and type 3
≥ 80 MPa for type 2 class 3 and type 4
5.5.1 Bond strength ≥5 MPa
5.5.2 ≥80 % of the value claimed but ≥5 MPa
5.6 Water sorption ≤40 µg/mm
5.7 Solubility ≤7,5 µg/mm
5.5 Bond strength
5.5.1 Special bonding system without macromechanical retention
If the manufacturer recommends a special bonding system without macromechanical retention, the strength
of bond to the material used for the substructure shall be not less than 5 MPa (see Tables 1 and 2).
Testing shall be carried out in accordance with 7.6.
5.5.2 Values higher than 5 MPa
If the manufacturer claims a value higher than 5 MPa for the bond strength, then the bond strength shall be
not less than 80 % of the value claimed with a minimum of 5 MPa.
Testing shall be carried out in accordance with 7.6.
5.6 Water sorption
The water sorption of the cured polymer-based crown and veneering material shall be not more than 40 µg/
mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.

ISO/DIS 10477:2025(en)
5.7 Solubility
The solubility in water of the cured polymer-based crown and veneering material shall be not more than
7,5 µg/mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.
5.8 Shade consistency
The colours of the cured polymer-based crown and veneering material from different batches (according to
6.1 and 6.2) shall show no more than a slight difference with the colour indicated by the manufacturer.
Testing shall be carried out in accordance with 7.8 and ISO 7491. This requirement is not applicable to
opaque resins.
5.9 Colour stability
The polymer-based crown and veneering material shall show no more than a slight change in colour.
Testing shall be carried out in accordance with 7.8 and ISO 7491. This requirement is not applicable to
opaque resins.
6 Sampling
6.1 For all tests
The test sample shall consist of one or more packages of one selected shade, corresponding to the purpose of
the test, from a single batch and contain sufficient material to carry out the specified tests, plus an allowance
for any necessary repetition of tests.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 20 ml of material may be needed.
6.2 For test of shade consistency
The sample for the test of shade consistency (5.8 and 7.8) shall consist of the same shade as in 6.1 but from
another batch.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 1 ml of material will be needed.
6.3 For test of colour stability
The sample for the test of colour stability (5.9 and 7.8) shall consist of two further shades of the
material. The shade of the resin sample shall consist of three different shades each of which correspond
to one representative shade of enamel resin, dentine resin and cervical resin. They should be selected in
consideration of its colouring components, if different colouring components are used.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 1 ml of material will be needed.
7 Measurement and test methods
7.1 General
7.1.1 Ambient test conditions
Tests shall be carried out at room conditions (23 ± 2) °C and (50 ± 20) % relative humidity.

ISO/DIS 10477:2025(en)
7.1.2 Water
Unless otherwise specified, the water to be used shall conform to ISO 3696:1987, Grade 3.
7.1.3 Preparation of test specimens
For the preparation of type 2 and type 3 polymer-based crown and veneering materials, reference shall
be made to the instruction for use that state the external energy source or sources recommended for the
materials to be tested. Care shall be taken to ensure that the energy source is fully functional.
Mix or otherwise prepare the polymer-based crown and veneering material in accordance with the
instruction for use and the test conditions specified in 7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.
If fully cured specimens are required for testing (7.4 to 7.8), it is important to ensure that the specimens
are homogeneous. There shall be no voids, clefts or air inclusions present by visual inspection without
magnification.
A separating medium which does not interfere with the setting reaction (e.g. 3 % solution of polyvinylstearyl
ether wax in hexane) may be used to facilitate removal of the specimen.
Printing (type 2, class 3 materials))
Print and process the polymer-based crown and veneering material in accordance with the instruction for use.
Milling (type 4 materials)
Mill in accordance with the instruction for use or saw the polymer-based crown and veneering material
or the polymer-based crown and veneering material in a similar way, taking care to avoid excess heat
generation
7.2 Visual inspection
Use visual inspection to determine conformity to Clause 8. The colour comparison in 7.8 shall be performed
in accordance with ISO 7491.
7.3 Depth of cure (only for type 2, class 2 if not opaque resin)
7.3.1 Apparatus
7.3.1.1 Split rings such as shown in Figure 1, (15 ± 1) mm in diameter and (1,0 ± 0,1) mm in height.
7.3.1.2 Two plates e.g. polished metal or glass, measuring approximately 20 mm × 20 mm × 5 mm.
7.3.1.3 Radiation source, as recommended in the instructions for use.
7.3.1.4 Hardness testing instrument, for HV 0,5.
7.3.1.5 Oven, set at (37 ± 1) °C.
7.3.2 Materials
7.3.2.1 White filter paper.
7.3.2.2 Film, colourless, transparent, (50 ± 30) μm thick.

ISO/DIS 10477:2025(en)
7.3.2.3 Polishing compound, precipitated calcium carbonate (CaCO ).
7.3.2.4 Muslin wheel, unstitched, 18-to 36-ply, having a diameter of 70 mm to 95 mm.
7.3.3 Procedure
7.3.3.1 Specimen preparation
Cover one plate (7.3.1.2) with a piece of white filter paper (7.3.2.1) followed by the film (7.3.2.2), and position
the split ring (7.3.1.1) upon it. Prepare the polymer-based crown and veneering material according to the
instruction for use, and place it into the split ring to a slight excess. Cover the polymer-based crown and
veneering material and the split ring with a second piece of film and the second plate (7.3.1.2), and extrude
the excess material. Remove the upper plate and irradiate the test specimen in the split ring through the
film, in accordance with the instruction for use. Remove the test specimen from the split ring.
Prepare three specimens and store them in water at (37 ± 1) °C for (24 ± 2) h. Carry out the hardness test on
the upper and lower surfaces of the specimens three times in accordance with ISO 6507-1.
7.3.4 Expression of results
Express the hardness of each surface as the mean of the three values obtained for it.
All three specimens shall meet the requirement of 5.2. Otherwise the polymer-based crown and veneering
material does not comply with the requirement of 5.2.
7.4 Surface finish
7.4.1 Apparatus (for type 2 class 3 and type 4 materials)
7.4.1.1 vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.2 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.4.1.3 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.4 Milling machine (for type 4), as recommended in the instructions for use.
7.4.1.5 Abrasive paper, at P220 or P320 according to ISO 6344-2.
7.4.1.6 Abrasive paper, at least P1000 according to ISO 6344-2.
7.4.2 Specimen preparation
For type 1, type 2 classes 1 and 2, and type 3 materials prepare a specimen according to 7.3.3. Polish the
test specimen prepared in accordance with the instruction for use. If no specific procedure is given, polish
according to the instructions provided under 7.4.3.
For type 2 class 3 materials Manufacture the specimen in the required dimension (round specimen,
diameter (15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1,0 ± 0,1) mm.
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper
(7.4.1.4).
After removing any flash, polish the surface, using P1000/P2000 of abrasive paper (7.4.1.5)

ISO/DIS 10477:2025(en)
For type 4 materials mill or saw the specimen in the required dimension (round specimen, diameter
(15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1,0 ± 0,1) mm.
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper
(7.4.1.4).
After removing any flash, polish the surface, using P1000/P2000 of abrasive paper (7.4.1.5)
7.4.3 Surface polishing
Grind (wet) the specimen on both sides and polish according to the instruction for use. If no specific
procedure is given polish for not longer than 1 min with a muslin wheel (7.3.2.4) at a circumferential speed of
(650 ± 350) m/min and with polishing compound (7.3.2.3). Keep at least 10 mm between the outer diameter
of the wheel and the stitching or other reinforcement.
Thoroughly clean the specimen by rinsing with water, blot dry, and visually inspect the surface. If the surface
of the specimen is glossy when visually inspected. the polymer-based veneering material complies with the
requirements of paragraph 5.3.
NOTE A wheel with a diameter of 70 mm rotating at 1 500 r/min has a circumferential speed of 330 m/min and a
100 mm diameter wheel rotating at 3 500 r/min has a circumferential speed of 1 100 m/min.

ISO/DIS 10477:2025(en)
Dimensions in millimetres
Key
1 glass or metal plates
2 split ring
3 retaining plate or former
Figure 1 — Mould for the preparation of test specimens for depth of cure, surface finish, water
sorption, solubility, shade consistency and colour stability
7.5 Flexural strength
7.5.1 Apparatus
7.5.1.1 Split stainless steel mould (for type 1, type 2 classes 1 and 2, and type 3 materials), coated with
a separating medium (e.g. 3 % solution of polyvinylstearyl ether wax in hexane), as shown in Figure 2, in an
appropriate mounting device.
7.5.1.2 Two glass or metal plates (for type 1, type 2 classes 1 and 2, and type 3 materials), of
approximately 30 mm × 30 mm × 2 mm.

ISO/DIS 10477:2025(en)
7.5.1.3 Small screw clamp (for type 1, type 2 classes 1 and 2, and type 3 materials).
7.5.1.4 Polymerization apparatus (for type 2 classes 1 and 2, and type 3 materials), as recommended in
the instruction for use.
7.5.1.5 vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.6 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.5.1.7 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.8 Milling machine (for type 4), as recommended in the instructions for use.
7.5.1.9 Saw (optional) suitable for cutting type 4 material
7.5.1.10 Oven, set at (37 ± 1) °C.
7.5.1.11 Flexural strength test apparatus, calibrated according to ISO 7500-1, to provide a constant
cross-head speed of (1,0 ± 0,3) mm/min. The apparatus consists of two rods (2 mm in diameter), mounted
parallel with 12 mm (according to ISO 5139) between centres, and a third rod (2 mm in diameter) centred
between, and parallel to the other two, so that the three rods in combination can be used to give a three-
point loading to the specimen. Other instruments with a constant loading rate of (50 ± 16) N/min may also
be used.
7.5.1.12 Micrometer, with an accuracy of 0,01 mm.
7.5.1.13 Timer, accurate to ±1 s.
7.5.2 Materials
7.5.2.1 White filter paper, as in 7.3.2.1.
7.5.2.2 Film, as in 7.3.2.2.
7.5.2.3 Abrasive paper, P 2000 according to ISO 6344-2.
7.5.2.4 Metal or glass plates, 1 quartz plate for UV photo-initiated material, no less than
30 mm × 10 mm × 2 mm.
7.5.2.5 Water, conforming to ISO 3696, Grade 2.

ISO/DIS 10477:2025(en)
Dimensions in millimetres
Figure 2 — Split mould for test specimens for the flexural test for type 1, type 2 classes 1 and 2, and
type 3 materials
7.5.3 Preparation of test specimens
Prepare five specimens according to 7.5.3.1 to 7.5.3.4. After preparation store the specimen in water (7.5.2.5)
at (37 ± 1) °C (7.5.1.10) until the start of testing (7.5.4). Specimens shall be plane-parallel for flexural testing.
7.5.3.1 Type 1 and type 2 class 1 materials
Cover one of the metal or glass plates (7.5.1.2) with the film (7.5.2.2), and position the mould (7.5.1.1) upon
it. Prepare the polymer-based crown and veneering material in accordance with the instruction for use and
immediately place it in the mould to a slight excess. Place a second piece of film onto the polymer-based
crown and veneering material in the mould and cover this with the second metal or glass plate. Apply
pressure to displace excess material by means of the clamp (7.5.1.3).
Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Fifteen minutes after polymerization, remove the specimen and carefully remove any flash by gently
abrading with abrasive paper (7.5.2.3), avoiding touching any other surface.
7.5.3.2 Type 2 class 2 and type 3 materials
For light (385 nm to 515 nm) photo-polymerization initiator materials cover with a glass plate as top plate;
for UV (below 385 nm) photo-polymerization initiator materials cover with a quartz plate as top plate.
Cover the bottom plate with the white filter paper (7.5.2.1), followed by the film (7.5.2.2), and position the
mould (7.5.1.1) upon it. Prepare the polymer-based crown and veneering material in accordance with the
instruction for use and fill the mould with the polymer-based crown and veneering material, as described
in 7.5.3.1. Place a second piece of film on the polymer-based crown and veneering material in the mould.
For light photo-polymerization initiator materials cover this with a glass plate; for photo-polymerization
initiator materials cover this with a quartz plate. Apply pressure to displace excess material by means of the
clamp (7.5.1.3).
Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Irradiate the specimen through the top glass or quartz plate, remove both plates and the white filter paper.
Irradiate the specimen from the other side. Fifteen minutes after polymerization remove the specimen and
carefully remove any flash by gently abrading with abrasive paper (7.5.2.3).

ISO/DIS 10477:2025(en)
7.5.3.3 Type 2 class 3 materials
Print and process the material in the required dimension (bar, >14 mm (length) x 4,0 ± 0,2 mm (width) x h
1,2 ± 0,2 mm (heights); at least 2 mm longer than the test span).
Remove the supports and carefully remove any flash by gently abrading with abrasive paper (7.5.2.3).
7.5.3.4 Type 4 materials
Saw or mill the material in the required dimension (bar, >14 mm (length) x 4,0 ± 0,2 mm (width) x h
1,2 ± 0,2 mm (heights); at least 2 mm longer than the test span).
Note see also ISO 5139, Annex A regarding the preparation of test pieces by sawing
7.5.4 Procedure
For type 1 to type
...

FINAL DRAFT
International
Standard
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour 2026-04-22
couronnes et facettes
Voting terminates on:
2026-06-17
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland Reference number
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 3
5 Requirements . 3
5.1 General .3
5.2 Depth of cure .4
5.2.1 General .4
5.2.2 Depth of cure (only type 2 class 2 materials) .4
5.3 Surface finish .4
5.4 Flexural strength.4
5.5 Bond strength .5
5.5.1 Special bonding system without macromechanical retention .5
5.5.2 Values higher than 5 MPa .5
5.6 Water sorption .5
5.7 Solubility .5
5.8 Shade consistency .5
5.9 Colour stability .6
6 Sampling . 6
6.1 For all tests.6
6.2 For test of shade consistency .6
6.3 For test of colour stability .6
7 Measurement and test methods . 6
7.1 General .6
7.1.1 Ambient test conditions .6
7.1.2 Water .6
7.1.3 Preparation of test specimens .6
7.2 Visual inspection .7
7.3 Depth of cure (only for type 2, class 2 if not opaque resin) .7
7.3.1 Apparatus .7
7.3.2 Materials .8
7.3.3 Procedure and specimen preparation.9
7.3.4 Expression of results .9
7.4 Surface finish .9
7.4.1 Apparatus (for type 2 class 3 and type 4 materials) .9
7.4.2 Materials .9
7.4.3 Specimen preparation .9
7.4.4 Surface polishing .10
7.5 Flexural strength.10
7.5.1 Apparatus .10
7.5.2 Materials .11
7.5.3 Preparation of test specimens .11
7.5.4 Procedure . 12
7.5.5 Expression of results . 13
7.6 Bond strength (only type 1, type 2 classes 1 and 2 and type 3 materials) . 13
7.6.1 Apparatus . 13
7.6.2 Materials .14
7.6.3 Preparation of test specimens . 15
7.6.4 Procedure . 15
7.6.5 Expression of results . 15

iii
7.7 Water sorption and solubility .16
7.7.1 Apparatus .16
7.7.2 Materials .16
7.7.3 Preparation of test specimen .17
7.7.4 Procedure .17
7.7.5 Expression of results .18
7.8 Shade consistency and colour stability .19
7.8.1 General .19
7.8.2 Apparatus .19
7.8.3 Materials .19
7.8.4 Preparation of test specimens . 20
7.8.5 Procedure . 20
7.8.6 Colour comparison.21
7.8.7 Expression of results for shade consistency . .21
7.8.8 Expression of results for colour stability .21
8 Packaging and labelling .21
8.1 Packaging .21
8.2 Labelling and instructions for use .21
Bibliography .25

iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of
(a) patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 10477:2020), which has been technically
revised.
The main changes are as follows:
— materials for additive manufacturing have been added to Clause 4 as type 2 class 3;
— materials for subtractive manufacturing have been added to Clause 4 as type 4;
— editorial updates have been made.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
hazards are not included in this document, but, for the assessment of possible biological hazards, reference
[1] [2]
should be made to ISO 10993-1 and ISO 7405 .

vi
FINAL DRAFT International Standard ISO/FDIS 10477:2026(en)
Dentistry — Polymer-based crown and veneering materials
1 Scope
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their
requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for
which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as
beads or wires.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 5139, Dentistry — Polymer-based composite machinable blanks
ISO 6344-2, Coated abrasives — Determination and designation of grain size distribution — Part 2: Macrogrit
sizes P12 to P220
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3: Microgrit
sizes P240 to P5000
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 18739, Dentistry — Vocabulary of process chain for CAD/CAM systems
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 18739 as well as the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp

3.1
polymer-based crown and veneering material
dental material supplied as a composite of powders and liquids or pastes that can contain monomers, either
inorganic fillers or polymeric fillers, or both, or pre-polymerized blocks or discs that can contain polymers
and inorganic fillers, and that, when polymerized or processed, is suitable for use as permanent dental
veneers or crowns
Note 1 to entry: Polymerization is effected either by mixing initiator(s) and activator(s) (“self-curing” materials) or by
external energy activation [by heat (“heat-curing” materials), photoactivated materials, either by visible light radiation
(“light-curing” materials) or by UV radiation ("UV-curing" materials), or both], or both (“dual-cure” materials).
Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or
crowns can be used without substructure or can be attached to a substructure.
3.2
dentine resin
pigmented and slightly translucent polymer-based crown and veneering material (3.1) used to simulate the
natural appearance of the dentine in a resin-based restoration or dental prosthesis
3.3
enamel resin
translucent, lightly pigmented polymer-based crown and veneering material (3.1) used to simulate the natural
appearance of enamel, including the incisal portion of a resin-based restoration or dental prosthesis
3.4
cervical resin
intensely pigmented slightly translucent polymer-based crown and veneering material (3.1) having colours
simulating those of cervical parts of natural teeth
3.5
opaque resin
polymer-based crown and veneering material (3.1) which, when applied to a substructure in accordance with
the manufacturer's instructions, bonds to the surface and forms a layer that masks the underlying colour
Note 1 to entry: Opaque resins are only required to fulfil the requirement of 5.5.
3.6
subtractive manufacturing
milling
process of machining, grinding or reducing a larger bulk object to create a smaller detailed three-dimensional
object using computer-aided design software and computer-aided manufacturing methods
Note 1 to entry: The term milling (3.6) is used in this document as it is a common term in dental technology and clinical
dentistry for the processing of these materials.
3.7
additive manufacturing
AM
printing
process of joining materials to make parts from 3D model data, usually layer upon layer, as opposed to
subtractive manufacturing (3.6) and formative manufacturing methodologies
Note 1 to entry: The term printing (3.7) is used in this document as it is a common term in dental technology and
clinical dentistry for the processing of these materials.

3.8
vat photopolymerization
VPP
additive manufacturing (3.7) process in which liquid photopolymer in a vat (3.9) is selectively cured by
photo-activated polymerization
Note 1 to entry: The liquid photopolymer can consist of monomers and photo-polymerization initiators and contain
fillers.
Note 2 to entry: The term printing (3.7) can be used instead of the term vat photopolymerization (3.8) in dental
technology and clinical dentistry for the processing of these materials.
3.9
vat
small tub, part of the polymerization device that contains the liquid photopolymer
3.10
computer-aided milling machine
computer-aided machining device designed for subtractive manufacturing (3.6) of dental restorations and
dental prostheses using rotary instruments for cutting and grinding
4 Classification
The polymer-based crown and veneering materials described in this document shall be classified according
to their activation system for polymerization:
— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing initiator(s)
and activator(s) (“self-curing” materials);
— Type 2: polymer-based crown and veneering materials whose setting is effected by the application of
energy from an external source (“external-energy-activated” materials), e.g. heat or radiation (visible or
UV range) or both;
— Class 1: polymer-based crown and veneering materials that do not contain a photo-polymerization
initiator;
— Class 2: polymer-based crown and veneering materials that contain a photopolymerization initiator
and are not intended for additive manufacturing (printing);
— Class 3: polymer-based crown and veneering materials that are intended for additive manufacturing,
e.g. vat photopolymerization (printing);
— Type 3: polymer-based crown and veneering materials whose setting is affected by mixing initiator(s)
and activator(s) and also by the application of energy from an external source (“dual-cure” materials);
— Type 4: polymer-based crown and veneering materials that are intended for subtractive manufacturing
(e.g. milling).
5 Requirements
5.1 General
The tests required for a crown and veneering material depend on the classification according to type and
class.
See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.

Table 1 — Test protocol
Type 2
Subclause Property Type 1 Type 3 Type 4
Class 1 Class 2 Class 3
a b
5.2 Depth of cure — — + — — —
Surface
a a a a
5.3 + + + + + +
finish
Flexural
a a a a
5.4 + + + + + +
strength
Bond
strength to
c c
5.5 + + + — + —
the frame-
work
Water
sorption, sol-
a a a a
5.6 to 5.9 ubility, shade + + + + + +
consistency,
colour
Key
+ carry out test
— do not test
a
If the material is opaque resin, do not test.
b
Not required because the curing process is inherently defined in the vat photopolymerization device and process (see 5.2.2).
c
Not required as these materials are not intended for veneering of frameworks.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.
5.2.2 Depth of cure (only type 2 class 2 materials)
For type 2 class 2 materials, the hardness of the bottom surface shall be not less than 70 % of that of the top
surface (see Table 2). This requirement is not applicable to opaque resins.
For type 1, type 2 class 1, and type 3 and type 4 materials, no requirement is specified.
For type 2 class 3 materials, no requirement is specified as the curing process is inherently defined in the
printing process.
5.3 Surface finish
A test specimen polished in accordance with 7.4 shall have a glossy surface.
Testing shall be carried out in accordance with 7.4. This requirement is not applicable to opaque resins.
5.4 Flexural strength
Flexural strength shall be at least 50 MPa for:
— type 1;
— type 2 classes 1 and 2;
— type 3.
Flexural strength shall be at least 80 MPa for type 2 class 3 and type 4 materials (see Table 2). This
requirement is not applicable to opaque resins.
Testing shall be carried out in accordance with 7.5.
Table 2 — Physical and chemical requirements
Subclause Property Requirement
Hardness of bottom surface ≥70 %
5.2 Depth of cure
of top surface
≥50 MPa for type 1, type 2 classes 1
and 2 and type 3
5.4 Flexural strength
≥ 80 MPa for type 2 class 3 and type 4
5.5.1 ≥5 MPa
Bond strength
≥80 % of the value claimed but
5.5.2
≥5 MPa
5.6 Water sorption ≤40 µg/mm
5.7 Solubility ≤7,5 µg/mm
5.5 Bond strength
5.5.1 Special bonding system without macromechanical retention
If the manufacturer recommends a special bonding system without macromechanical retention, the strength
of bond to the material used for the substructure shall be not less than 5 MPa (see Table 1 and Table 2).
Testing shall be carried out in accordance with 7.6.
5.5.2 Values higher than 5 MPa
If the manufacturer claims a value higher than 5 MPa for the bond strength, then the bond strength shall be
not less than 80 % of the value claimed with a minimum of 5 MPa.
Testing shall be carried out in accordance with 7.6.
5.6 Water sorption
The water sorption of the cured polymer-based crown and veneering material shall be not more than 40 µg/
mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.
5.7 Solubility
The solubility in water of the cured polymer-based crown and veneering material shall be not more than 7,5
µg/mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.
5.8 Shade consistency
The colours of the cured polymer-based crown and veneering material from different batches (according to
6.1 and 6.2) shall show no more than a slight difference with the colour indicated by the manufacturer.
Testing shall be carried out in accordance with 7.8 and ISO 7491.

5.9 Colour stability
The polymer-based crown and veneering material shall show no more than a slight change in colour.
Testing shall be carried out in accordance with 7.8 and ISO 7491.
6 Sampling
6.1 For all tests
The test sample shall consist of one or more packages of one selected shade, corresponding to the purpose of
the test, from a single batch and contain sufficient material to carry out the specified tests, plus an allowance
for any necessary repetition of tests.
For type 1, type 2 classes 1 and 2 and type 3 materials, an amount of 20 ml of material is recommended.
6.2 For test of shade consistency
The sample for the test of shade consistency (5.8 and 7.8) shall consist of the same shade as in 6.1 but from
another batch.
For type 1, type 2 classes 1 and 2, and type 3 materials, an amount of 1 ml of material is recommended.
6.3 For test of colour stability
The sample for the test of colour stability (5.9 and 7.8) shall consist of two further shades of the
material. The shade of the resin sample shall consist of three different shades each of which correspond
to one representative shade of enamel resin, dentine resin and cervical resin. They should be selected in
consideration of its colouring components, if different colouring components are used.
For type 1, type 2 classes 1 and 2 and type 3 materials, an amount of 1 ml of material is recommended.
7 Measurement and test methods
7.1 General
7.1.1 Ambient test conditions
Tests shall be carried out at room conditions (23 ± 2) °C and (50 ± 20) % relative humidity.
7.1.2 Water
Unless otherwise specified, the water to be used shall conform to ISO 3696:1987, Grade 3.
7.1.3 Preparation of test specimens
For the preparation of type 2 and type 3 polymer-based crown and veneering materials, reference shall
be made to the instruction for use that state the external energy source or sources recommended for the
materials to be tested. Care shall be taken to ensure that the energy source is fully functional.
Mix or otherwise prepare the polymer-based crown and veneering material in accordance with the
instruction for use and the test conditions specified in 7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.
If fully cured specimens are required for testing (7.4 to 7.8), the specimens shall behomogeneous. There
shall be no voids, clefts or air inclusions present by visual inspection without magnification.

A separating medium which does not interfere with the setting reaction (e.g. 3 % solution of polyvinylstearyl
ether wax in hexane) can be used to facilitate removal of the specimen.
For the preparation of type 2 class 3 polymer-based crown and veneering materials, reference shall be made
to the instructions for use that state the vat photopolymerization device and process specification.
For the preparation of type 4 polymer-based crown and veneering materials, reference shall be made to
the instructions for use that state the computer-aided milling machine and process specification. It shall be
taking care to avoid excess heat generation.
7.2 Visual inspection
Use visual inspection to determine conformity to Clause 8. The colour comparison in 7.8 shall be performed
in accordance with ISO 7491.
7.3 Depth of cure (only for type 2, class 2 if not opaque resin)
7.3.1 Apparatus
7.3.1.1 Split rings, such as shown in Figure 1, (15 ± 1) mm in diameter and (1,0 ± 0,1) mm in height.

Dimensions in millimetres
Key
1 glass or metal plates
2 split ring
3 retaining plate or former
Figure 1 — Mould for the preparation of test specimens for depth of cure, surface finish, water
sorption, solubility, shade consistency and colour stability
7.3.1.2 Two plates, e.g. polished metal or glass, measuring approximately 20 mm × 20 mm × 5 mm.
7.3.1.3 Radiation source, as recommended in the instructions for use.
7.3.1.4 Hardness testing instrument, for HV 0,5.
7.3.1.5 Oven, set at (37 ± 1) °C.
7.3.2 Materials
7.3.2.1 White filter paper.
7.3.2.2 Film, colourless, transparent, (50 ± 30) μm thick.

7.3.3 Procedure and specimen preparation
Cover one plate with a piece of white filter paper followed by the film and position the split ring upon it.
Prepare the polymer-based crown and veneering material according to the instruction for use and place it
into the split ring to a slight excess. Cover the polymer-based crown and veneering material and the split
ring with a second piece of film and the second plate and extrude the excess material. Remove the upper
plate and irradiate the test specimen in the split ring through the film in accordance with the instruction for
use. Remove the test specimen from the split ring.
Prepare three specimens and store them in water at (37 ± 1) °C for (24 ± 2) h. Carry out the hardness test on
the upper and lower surfaces of the specimens three times in accordance with ISO 6507-1.
7.3.4 Expression of results
Express the hardness of each surface as the mean of the three values obtained for it.
All three specimens shall meet the requirement of 5.2. Otherwise the polymer-based crown and veneering
material does not conform with the requirement of 5.2.
7.4 Surface finish
7.4.1 Apparatus (for type 2 class 3 and type 4 materials)
7.4.1.1 Vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.2 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.4.1.3 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.4 Computer-aided milling machine (for type 4), as recommended in the instructions for use.
7.4.2 Materials
7.4.2.1 Abrasive paper, at P220 (in accordance with ISO 6344-2) or P320 (in accordance with ISO 6344-3).
7.4.2.2 Abrasive paper, at least P1000 or finer (in accordance with ISO 6344-3).
7.4.2.3 Polishing compound, precipitated calcium carbonate (CaCO ).
7.4.2.4 Muslin wheel, unstitched, 18-to 36-ply, having a diameter of 70 mm to 95 mm.
7.4.3 Specimen preparation
For type 1, type 2 classes 1 and 2 and type 3 materials, prepare a specimen according to 7.3.3. Polish the test
specimen prepared in accordance with the instruction for use. If no specific procedure is given, polish in
accordance with the instructions provided under 7.4.3.
For type 2 class 3 materials, manufacture the specimen in the required dimension [round specimen, diameter
(15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1.0 ± 0,1) mm].
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface using P1000 or finer of abrasive paper.
For type 4 materials, mill or saw the specimen in the required dimension [round specimen, diameter (15 ± 1)
mm, heights (1.0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1.0 ± 0,1) mm].

Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface using P1000 or finer of abrasive paper.
7.4.4 Surface polishing
Grind (wet) the specimen on both sides and polish according to the instruction for use. If no specific
procedure is given, polish for not longer than 1 min with a muslin wheel at a circumferential speed of (650
± 350) m/min and with polishing compound. Keep at least 10 mm between the outer diameter of the wheel
and the stitching or other reinforcement.
Thoroughly clean the specimen by rinsing with water, blot dry, and visually inspect the surface. If the surface
of the specimen is glossy when visually inspected. the polymer-based veneering material conforms with the
requirements of 5.3.
NOTE A wheel with a diameter of 70 mm rotating at 1 500 r/min has a circumferential speed of 330 m/min and a
100 mm diameter wheel rotating at 3 500 r/min has a circumferential speed of 1 100 m/min.
7.5 Flexural strength
7.5.1 Apparatus
7.5.1.1 Split stainless steel mould (for type 1, type 2 classes 1 and 2 and type 3 materials), coated with
a separating medium (e.g. 3 % solution of polyvinylstearyl ether wax in hexane), as shown in Figure 2, in an
appropriate mounting device.
Dimensions in millimetres
Figure 2 — Split mould for test specimens for the flexural test for type 1, type 2 classes 1 and 2 and
type 3 materials
7.5.1.2 Two glass or metal plates (for type 1, type 2 classes 1 and 2 and type 3 materials), of approximately
30 mm × 30 mm × 2 mm.
7.5.1.3 Small screw clamp (for type 1, type 2 classes 1 and 2, and type 3 materials).
7.5.1.4 Polymerization apparatus (for type 2 classes 1 and 2, and type 3 materials), as recommended in
the instruction for use.
7.5.1.5 Vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.6 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.5.1.7 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.8 Computer-aided milling machine (for type 4), as recommended in the instructions for use.
7.5.1.9 Saw, (optional) suitable for cutting type 4 material.
7.5.1.10 Oven, set at (37 ± 1) °C.
7.5.1.11 Flexural strength test apparatus, calibrated in accordance with ISO 7500-1, to provide a constant
cross-head speed of (1,0 ± 0,3) mm/min. The apparatus consists of two rods (2 mm in diameter), mounted
parallel with 12 mm or 20 mm (for 25 mm specimen) (in accordance with ISO 5139) between centres and
a third rod (2 mm in diameter) centred between and parallel to the other two, so that the three rods in
combination can be used to give a three-point loading to the specimen. Other instruments with a constant
loading rate of (50 ± 16) N/min may also be used.
7.5.1.12 Micrometer, with an accuracy of 0,01 mm.
7.5.1.13 Timer, accurate to ± 1 s.
7.5.2 Materials
7.5.2.1 White filter paper, as in 7.3.2.1.
7.5.2.2 Film, as in 7.3.2.2.
7.5.2.3 Abrasive paper, at P220 (in accordance with ISO 6344-2) or P320 (in accordance with ISO 6344-3),
as in 7.4.2.1.
7.5.2.4 Abrasive paper, at least P1000 or finer (in accordance with ISO 6344-3), as in 7.4.2.2.
7.5.2.5 Metal or glass plates, 1 quartz plate for UV photo-activated material, no less than 30 mm × 10 mm
× 2 mm.
7.5.2.6 Water, conforming to ISO 3696:1987, Grade 2.
7.5.3 Preparation of test specimens
7.5.3.1 General
Prepare five specimens according to 7.5.3.1 to 7.5.3.4. After preparation, store the specimen in water (7.5.2.6)
at (37 ± 1) °C (7.5.1.10) until the start of testing (7.5.4). Specimens shall be plane-parallel for flexural testing.
7.5.3.2 Type 1 and type 2 class 1 materials
Cover one of the metal or glass plates with the film and position the mould upon it. Prepare the polymer-
based crown and veneering material in accordance with the instruction for use and immediately place it
in the mould to a slight excess. Place a second piece of film onto the polymer-based crown and veneering
material in the mould and cover this with the second metal or glass plate. Apply pressure to displace excess
material by means of the clamp.

Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Fifteen minutes after polymerization, remove the specimen and carefully remove any flash by gently
abrading with abrasive paper (7.5.2.3), avoiding touching any other surface.
7.5.3.3 Type 2 class 2 and type 3 materials
For light (385 nm to 515 nm) photopolymerization initiator materials, cover with a glass plate as top plate.
For UV (below 385 nm) photopolymerization initiator materials, cover with a quartz plate as top plate.
Cover the bottom plate with the white filter paper, followed by the film, and position the mould upon it.
Prepare the polymer-based crown and veneering material in accordance with the instruction for use and
fill the mould with the polymer-based crown and veneering material, as described in 7.5.3.2. Place a second
piece of film on the polymer-based crown and veneering material in the mould. For light photopolymerization
initiator materials cover this with a glass p
...

ISO/DISFDIS 10477
ISO/TC 106/SC 2
Secretariat: ANSI
Date: 2026-02-0204-08
Dentistry — Polymer-based crown and veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour couronnes et facettes
DISFDIS stage
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ISO/DISFDIS 10477:2026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 10477:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Classification . iii
Requirements . iii
General . iii
Depth of cure . iii
Surface finish. iii
Flexural strength . iii
Bond strength . iii
Water sorption . iii
Solubility . iii
Shade consistency . iii
Colour stability . iii
Sampling . iii
For all tests. iii
For test of shade consistency . iii
For test of colour stability . iii
Measurement and test methods . iii
General . iii
Visual inspection . iii
Depth of cure (only for type 2, class 2 if not opaque resin) . iii
Surface finish. iii
Flexural strength . iii
Bond strength (only type 1, type 2 classes 1 and 2, and type 3 materials) . iii
Water sorption and solubility . iii
Shade consistency and colour stability . iii
Packaging and labelling . iii
Packaging . iii
Labelling and instructions for use . iii
Bibliography . iii
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification. 3
5 Requirements . 4
5.1 General. 4
5.2 Depth of cure . 4
5.3 Surface finish . 5
5.4 Flexural strength . 5
iii
ISO/DISFDIS 10477:2026(en)
5.5 Bond strength . 5
5.6 Water sorption . 6
5.7 Solubility . 6
5.8 Shade consistency . 6
5.9 Colour stability . 6
6 Sampling . 6
6.1 For all tests . 6
6.2 For test of shade consistency . 6
6.3 For test of colour stability . 6
7 Measurement and test methods . 7
7.1 General. 7
7.2 Visual inspection . 7
7.3 Depth of cure (only for type 2, class 2 if not opaque resin) . 7
7.4 Surface finish . 9
7.5 Flexural strength . 11
7.6 Bond strength (only type 1, type 2 classes 1 and 2 and type 3 materials) . 14
7.7 Water sorption and solubility . 19
7.8 Shade consistency and colour stability . 22
8 Packaging and labelling . 24
8.1 Packaging . 24
8.2 Labelling and instructions for use . 25
Bibliography . 29

iv
ISO/DISFDIS 10477:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that this
may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 10477:2020), which has been technically revised.
The main changes are as follows:
— addition of materials for additive manufacturing in Clause 4have been added to Clause 4 as Typetype 2
Classclass 3;
— addition of materials for subtractive manufacturing in Clause 4have been added to Clause 4 as Typetype
4;
— editorial updates have been made.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/DISFDIS 10477:2026(en)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
hazards are not included in this document, but it is recommended that, for the assessment of possible
[1] [2]
biological hazards, reference should be made to ISO 10993-1 ISO 10993-1 and ISO 7405 .ISO 7405.
vi
ISO/DISFDIS 10477:2026(en)
Dentistry — Polymer-based crown and veneering materials
1 Scope
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their
requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for
which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as
beads or wires.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 5139, Dentistry — Polymer-based composite machinable blanks
ISO 6344-2, Coated abrasives — Determination and designation of grain size distribution — Part 2: Macrogrit
sizes P12 to P220
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3: Microgrit
sizes P240 to P5000
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 18739, Dentistry — Vocabulary of process chain for CAD/CAM systems
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
Formatted: RefNorm
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 , ISO 18739 as well as the
following apply.
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
ISO/DISFDIS 10477:2026(en)
3.1
polymer-based crown and veneering material
dental material supplied as a composite of powders and liquids or pastes that can contain monomers, either
inorganic fillers or polymeric fillers, or both, or pre-polymerized blocks or discs that can contain polymers and
inorganic fillers, and that, when polymerized or processed, is suitable for use as permanent dental veneers or
crowns
Note 1 to entry: Polymerization is effected either by mixing initiator(s) and activator(s) (“self-curing” materials) or by
external energy activation [by heat (“heat-curing” materials), photoactivated materials, either by visible light radiation
(“light-curing” materials) or by UV radiation ("UV-curing" materials), or both], or both (“dual-cure” materials).
Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or
crowns can be used without substructure or can be attached to a substructure.
3.2
dentine resin
pigmented and slightly translucent polymer-based crown and veneering material (3.1)(3.1) used to simulate
the natural appearance of the dentine in a resin-based restoration or dental prosthesis
3.3
enamel resin
translucent, lightly pigmented polymer-based crown and veneering material (3.1) (3.1)(3.1) used to simulate
the natural appearance of enamel, including the incisal portion of a resin-based restoration or dental
prosthesis
3.4
cervical resin
intensely pigmented slightly translucent polymer-based crown and veneering material (3.1)(3.1) having
colours simulating those of cervical parts of natural teeth
3.5
opaque resin
polymer-based crown and veneering material (3.1)(3.1) which, when applied to a substructure in accordance
with the manufacturer's instructions, bonds to the surface and forms a layer that masks the underlying colour
Note 1 to entry: Opaque resins are only required to fulfil the requirement of 5.5.5.5.
3.6
subtractive manufacturing
Formatted: Default Paragraph Font
milling
process of machining, grinding or reducing a larger bulk object to create a smaller detailed three-dimensional
object using computer-aided design software and computer-aided manufacturing methods
Note 1 to entry: The term milling (3.6)(3.6) is used in this document as it is a common term in dental technology and
clinical dentistry for the processing of these materials.
3.7
additive manufacturing
Formatted: Default Paragraph Font
AM
printing
process of joining materials to make parts from 3D model data, usually layer upon layer, as opposed to
subtractive manufacturing (3.6)(3.6) and formative manufacturing methodologies
Note 1 to entry: The term printing (3.7)(3.7) is used in this document as it is a common term in dental technology and
clinical dentistry for the processing of these materials.
ISO/DISFDIS 10477:2026(en)
3.8
vat photopolymerization
Formatted: Default Paragraph Font
VPP
additive manufacturing (3.7)(3.7) process in which liquid photopolymer in a vat (3.9)(3.9) is selectively cured
by photo-activated polymerization
Note 1 to entry: The liquid photopolymer can consist of monomers, and photo-polymerization initiators and contain
fillers.
Note 2 to entry: The term printing (3.7) is possibly(3.7) can be used instead of the term “vat photopolymerization (3.8)
”(3.8) in dental technology and clinical dentistry for the processing of these materials.
3.9
vat
small tub, part of the polymerization device that contains the liquid photopolymer
3.10
computer-aided milling machine
Formatted: Default Paragraph Font
computer-aided machining device designed for subtractive manufacturing (3.6)(3.6) of dental restorations
and dental prostheses using rotary instruments for cutting and grinding
4 Classification
The polymer-based crown and veneering materials described in this document shall be classified according
to their activation system for polymerization.:
— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing initiator(s) and
activator(s) (“self-curing” materials);
— Type 2: polymer-based crown and veneering materials whose setting is effected by the application of
energy from an external source (“external-energy-activated” materials), such ase.g. heat or radiation
(visible or UV range) or both;
— Class 1: polymer-based crown and veneering materials that do not contain a photo-polymerization
initiator;
— Class 2: polymer-based crown and veneering materials that contain a photopolymerization initiator
and are not intended for additive manufacturing (printing);
— Class 3: polymer-based crown and veneering materials that are intended for additive manufacturing,
e.g. vat photopolymerization (printing);
— Type 3: polymer-based crown and veneering materials whose setting is affected by mixing initiator(s) and
activator(s) and also by the application of energy from an external source (“dual-cure” materials);
— Type 4: polymer-based crown and veneering materials that are intended for subtractive manufacturing
(e.g. milling).
ISO/DISFDIS 10477:2026(en)
5 Requirements
5.1 General
The tests required for a crown and veneering material depend on the classification according to type and class.
See Table 1Table 1 for the necessity of the specific tests described in 5.25.2 to 5.9.5.9.
Table 1 — Test protocol
Type 2
Formatted: Font: Bold
Subclause Property Type 1 Type 3 Type 4
Class 1 Class 2 Class 3
Formatted: Font: Bold
a b
Formatted: Font: Bold
5.25.2 Depth of cure — — + — — —
a a a a
Formatted: Font: Bold
5.35.3 Surface finish + + + + + +
Formatted: Font: Bold
Flexural
a a a a
5.45.4 + + + + + +
strength
Formatted: Font: Bold
Bond strength
Formatted: Table header (+)
c c
5.55.5 to the + + + — + —
Formatted Table
framework
Water
sorption,
5.6 5.6
to 5.9 to solubility,
a a a a
+ + + + + +
5.9 shade
consistency,
colour
Key
+ carry out test
— do not test
a
If the material is opaque resin, do not test.
b
Not required because the curing process is inherently defined in the vat photopolymerization device and process (see
5.2.2).5.2.2).
c
Not required as these materials are not intended for veneering of frameworks.
Key
+ carry out test
— do not test
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.7.3.
5.2.2 Depth of cure (only type 2 class 2 materials)
For type 2 class 2 materials, the hardness of the bottom surface shall be not less than 70 % of that of the top
surface (see Table 2).Table 2). This requirement is not applicable to opaque resins.
For type 1, type 2 class 1, and type 3 and type 4 materials, no requirement is specified.
For type 2 class 3 materials, no requirement is specified as the curing process is inherently defined in the
printing process.
ISO/DISFDIS 10477:2026(en)
5.3 Surface finish
A test specimen polished in accordance with 7.47.4 shall have a glossy surface.
Testing shall be carried out in accordance with 7.4.7.4. This requirement is not applicable to opaque resins.
5.4 Flexural strength
Flexural strength shall be at least 50 MPa for :
— type 1 and ;
— type 2 classes 1 and 2 and ;
— type 3, and.
Flexural strength shall be at least 80 MPa for type 2 class 3 and type 4 materials (see Table 2).Table 2). This
requirement is not applicable to opaque resins.
Testing shall be carried out in accordance with 7.5.7.5.
Table 2
— Physical and chemical requirements
Formatted: Table title
Subclause Property Requirement
Formatted: Font: Bold
Formatted: Font: Bold
Hardness of bottom surface ≥70 %
5.25.2 Depth of cure
of top surface
≥50 MPa for type 1, type 2 classes 1
and 2 and type 3
5.45.4 Flexural strength
≥ 80 MPa for type 2 class 3 and type
5.5.15.5.1 ≥5 MPa
Bond strength
≥80 % of the value claimed but
5.5.25.5.2
≥5 MPa
5.65.6 Water sorption ≤40 µg/mm
5.7 3
5.7 Solubility ≤7,5 µg/mm
5.5 Bond strength
5.5.1 Special bonding system without macromechanical retention
If the manufacturer recommends a special bonding system without macromechanical retention, the strength
of bond to the material used for the substructure shall be not less than 5 MPa (see Table 1 and Table 2).Table
1 and Table 2).
Testing shall be carried out in accordance with 7.6.7.6.
5.5.2 Values higher than 5 MPa
If the manufacturer claims a value higher than 5 MPa for the bond strength, then the bond strength shall be
not less than 80 % of the value claimed with a minimum of 5 MPa.
Testing shall be carried out in accordance with 7.6.7.6.
ISO/DISFDIS 10477:2026(en)
5.6 Water sorption
The water sorption of the cured polymer-based crown and veneering material shall be not more than 40
µg/mm (see Table 2).Table 2).
Testing shall be carried out in accordance with 7.7.7.7. This requirement is not applicable to opaque resins.
5.7 Solubility
The solubility in water of the cured polymer-based crown and veneering material shall be not more than 7,5
µg/mm (see Table 2).Table 2).
Testing shall be carried out in accordance with 7.7.7.7. This requirement is not applicable to opaque resins.
5.8 Shade consistency
The colours of the cured polymer-based crown and veneering material from different batches (according to
6.1 and 6.2)6.1 and 6.2) shall show no more than a slight difference with the colour indicated by the
manufacturer.
Testing shall be carried out in accordance with 7.8 and ISO 7491 7.8 and ISO 7491.
5.9 Colour stability
The polymer-based crown and veneering material shall show no more than a slight change in colour.
Testing shall be carried out in accordance with 7.87.8 and ISO 7491.
6 Sampling
6.1 For all tests
The test sample shall consist of one or more packages of one selected shade, corresponding to the purpose of
the test, from a single batch and contain sufficient material to carry out the specified tests, plus an allowance
for any necessary repetition of tests.
For type 1, type 2 classes 1 and 2, and type 3 materials, an amount of 20 ml of material is recommended.
6.2 For test of shade consistency
The sample for the test of shade consistency (5.8(5.8 and 7.8)7.8) shall consist of the same shade as in 6.16.1
but from another batch.
For type 1, type 2 classes 1 and 2, and type 3 materials, an amount of 1 ml of material is recommended.
6.3 For test of colour stability
The sample for the test of colour stability (5.9 and 7.8)(5.9 and 7.8) shall consist of two further shades of the
material. The shade of the resin sample shall consist of three different shades each of which correspond to one
representative shade of enamel resin, dentine resin and cervical resin. They should be selected in
consideration of its colouring components, if different colouring components are used.
For type 1, type 2 classes 1 and 2, and type 3 materials, an amount of 1 ml of material is recommended.
ISO/DISFDIS 10477:2026(en)
7 Measurement and test methods
7.1 General
7.1.1 Ambient test conditions
Tests shall be carried out at room conditions (23 ± 2) °C and (50 ± 20) % relative humidity.
7.1.2 Water
Unless otherwise specified, the water to be used shall conform to ISO 3696:1987, Grade 3.
7.1.3 Preparation of test specimens
For the preparation of type 2 and type 3 polymer-based crown and veneering materials, reference shall be
made to the instruction for use that state the external energy source or sources recommended for the
materials to be tested. Care shall be taken to ensure that the energy source is fully functional.
Mix or otherwise prepare the polymer-based crown and veneering material in accordance with the instruction
for use and the test conditions specified in 7.1.1.7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.
If fully cured specimens are required for testing (7.4 to 7.8), it is important to ensure that the specimens are
homogeneous.(7.4 to 7.8), the specimens shall behomogeneous. There shall be no voids, clefts or air inclusions
present by visual inspection without magnification.
A separating medium which does not interfere with the setting reaction (e.g. 3 % solution of polyvinylstearyl
ether wax in hexane) can be used to facilitate removal of the specimen.
For the preparation of type 2 class 3 polymer-based crown and veneering materials, reference shall be made
to the instructions for use that state the vat photopolymerization device and process specification.
For the preparation of type 4 polymer-based crown and veneering materials, reference shall be made to the
instructions for use that state the computer-aided milling machine and process specification. It shall be taking
care to avoid excess heat generation.
7.2 Visual inspection
Use visual inspection to determine conformity to Clause 8. The colour comparison in 7.8Clause 8. The colour
comparison in 7.8 shall be performed in accordance with ISO 7491.
7.3 Depth of cure (only for type 2, class 2 if not opaque resin)
7.3.1 Apparatus
7.3.1.1 Split rings, such as shown in Figure 1,Figure 1, (15 ± 1) mm in diameter and (1,0 ± 0,1) mm in
height.
ISO/DISFDIS 10477:2026(en)
Dimensions in millimetres
Key
1 glass or metal plates
2 split ring
3 retaining plate or former
Figure 1— Mould for the preparation of test specimens for depth of cure, surface finish, water
sorption, solubility, shade consistency and colour stability
7.3.1.2 Two plates, e.g. polished metal or glass, measuring approximately 20 mm × 20 mm × 5 mm.
7.3.1.3 Radiation source, as recommended in the instructions for use.
7.3.1.4 Hardness testing instrument, for HV 0,5.
7.3.1.5 Oven, set at (37 ± 1) °C.
7.3.2 Materials
7.3.2.1 White filter paper.
7.3.2.2 Film, colourless, transparent, (50 ± 30) μm thick.
7.3.3 Procedure and Specimenspecimen preparation
Cover one plate with a piece of white filter paper followed by the film, and position the split ring upon it.
Prepare the polymer-based crown and veneering material according to the instruction for use, and place it
into the split ring to a slight excess. Cover the polymer-based crown and veneering material and the split ring
with a second piece of film and the second plate, and extrude the excess material. Remove the upper plate and
irradiate the test specimen in the split ring through the film, in accordance with the instruction for use.
Remove the test specimen from the split ring.
ISO/DISFDIS 10477:2026(en)
Prepare three specimens and store them in water at (37 ± 1) °C for (24 ± 2) h. Carry out the hardness test on
the upper and lower surfaces of the specimens three times in accordance with ISO 6507-1.
7.3.4 Expression of results
Express the hardness of each surface as the mean of the three values obtained for it.
All three specimens shall meet the requirement of 5.2.5.2. Otherwise the polymer-based crown and veneering
material does not conform with the requirement of 5.2.5.2.
7.4 Surface finish
7.4.1 Apparatus (for type 2 class 3 and type 4 materials)
7.4.1.1 vatVat photopolymerization device (for type 2 class 3), as recommended in the instructions for
use.
7.4.1.2 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.4.1.3 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.4 Computer-aided milling machine (for type 4), as recommended in the instructions for use.
7.4.2 Materials
7.4.2.1 Abrasive paper, at P220 (in accordance with ISO 6344-2) or P320 (in accordance with ISO 6344-
3).
7.4.2.2 Abrasive paper, at least P1000 or finer (in accordance with ISO 6344-3).
7.4.2.3 Polishing compound, precipitated calcium carbonate (CaCO ).
7.4.2.4 Muslin wheel, unstitched, 18-to 36-ply, having a diameter of 70 mm to 95 mm.
7.4.3 Specimen preparation
For type 1, type 2 classes 1 and 2, and type 3 materials, prepare a specimen according to 7.3.3.7.3.3. Polish the
test specimen prepared in accordance with the instruction for use. If no specific procedure is given, polish in
accordance with the instructions provided under 7.4.3.7.4.3.
For type 2 class 3 materials Manufacture, manufacture the specimen in the required dimension ([round
specimen, diameter (15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1.0
± 0,1) mm).].
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface, using P1000 or finer of abrasive paper.
For type 4 materials, mill or saw the specimen in the required dimension ([round specimen, diameter (15 ±
1) mm, heights (1.0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1.0 ± 0,1) mm).].
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface, using P1000 or finer of abrasive paper.
ISO/DISFDIS 10477:2026(en)
7.4.4 Surface polishing
Grind (wet) the specimen on both sides and polish according to the instruction for use. If no specific procedure
is given, polish for not longer than 1 min with a muslin wheel at a circumferential speed of (650 ± 350) m/min
and with polishing compound. Keep at least 10 mm between the outer diameter of the wheel and the stitching
or other reinforcement.
Thoroughly clean the specimen by rinsing with water, blot dry, and visually inspect the surface. If the surface
of the specimen is glossy when visually inspected. the polymer-based veneering material conforms with the
requirements of 5.3.5.3.
NOTE A wheel with a diameter of 70 mm rotating at 1 500 r/min has a circumferential speed of 330 m/min and a
100 mm diameter wheel rotating at 3 500 r/min has a circumferential speed of 1 100 m/min.
Dimensions in millimetres
Key
1 glass or metal plates
2 split ring
3 retaining plate or former
Figure 1 — Mould for the preparation of test specimens for depth of cure, surface finish, water
sorption, solubility, shade consistency and colour stability
ISO/DISFDIS 10477:2026(en)
7.5 Flexural strength
7.5.1 Apparatus
7.5.1.1 Split stainless steel mould (for type 1, type 2 classes 1 and 2, and type 3 materials), coated with a
separating medium (e.g. 3 % solution of polyvinylstearyl ether wax in hexane), as shown in Figure 2 ,Figure 2,
in an appropriate mounting device.
Dimensions in millimetres
Figure 2 — Split mould for test specimens for the flexural test for type 1, type 2 classes 1 and 2, and
type 3 materials
7.5.1.2 Two glass or metal plates (for type 1, type 2 classes 1 and 2, and type 3 materials), of
approximately 30 mm × 30 mm × 2 mm.
7.5.1.3 Small screw clamp (for type 1, type 2 classes 1 and 2, and type 3 materials).
7.5.1.4 Polymerization apparatus (for type 2 classes 1 and 2, and type 3 materials), as recommended in
the instruction for use.
7.5.1.5 vatVat photopolymerization device (for type 2 class 3), as recommended in the instructions for
use.
ISO/DISFDIS 10477:2026(en)
7.5.1.6 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.5.1.7 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.8 Computer-aided milling machine (for type 4), as recommended in the instructions for use.
7.5.1.9 Saw, (optional) suitable for cutting type 4 material.
7.5.1.10 Oven, set at (37 ± 1) °C.
7.5.1.11 Flexural strength test apparatus, calibrated in accordance with ISO 7500-1, to provide a constant
cross-head speed of (1,0 ± 0,3) mm/min. The apparatus consists of two rods (2 mm in diameter), mounted
parallel with 12 mm or 20 mm (for 25 mm specimen) (in accordance with ISO 5139) between centres, and a
third rod (2 mm in diameter) centred between, and parallel to the other two, so that the three rods in
combination can be used to give a three-point loading to the specimen. Other instruments with a constant
loading rate of (50 ± 16) N/min may also be used.
7.5.1.12 Micrometer, with an accuracy of 0,01 mm.
7.5.1.13 Timer, accurate to ± 1 s.
7.5.2 Materials
7.5.2.1 White filter paper, as in 7.3.2.1.7.3.2.1.
7.5.2.2 Film, as in 7.3.2.2.
7.5.2.2 Film, as in 7.3.2.2.
7.5.2.3 Abrasive paper, at P220 (in accordance with ISO 6344-2) or P320 (in accordance with ISO 6344-
3), as in 7.4.2.1.7.4.2.1.
7.5.2.4 Abrasive paper, at least P1000 or finer (in accordance with ISO 6344-3), as in7.4.2.2. 7.4.2.2.
7.5.2.5 Metal or glass plates, 1 quartz plate for UV photo-activated material, no less than 30 mm × 10 mm
× 2 mm.
7.5.2.6 Water, conforming to ISO 3696:1987, Grade 2.
7.5.3 Preparation of test specimens
7.5.3.1 General
Prepare five specimens according to 7.5.3.1 to 7.5.3.4. After preparation store the specimen in water (7.5.2.6)
at (37 ± 1) °C ( 7.5.1.10) until the start of testing (7.5.4).7.5.3.1 to 7.5.3.4. After preparation, store the specimen
in water (7.5.2.6) at (37 ± 1) °C (7.5.1.10) until the start of testing (7.5.4). Specimens shall be plane-parallel
for flexural testing.
7.5.3.2 Type 1 and type 2 class 1 materials
Cover one of the metal or glass plates with the film, and position the mould upon it. Prepare the polymer-based
crown and veneering material in accordance with the instruction for use and immediately place it in the mould
to a slight excess. Place a second piece of film onto the polymer-based crown and veneering material in the
mould and cover this with the second metal or glass plate. Apply pressure to displace excess material by means
of the clamp.
ISO/DISFDIS 10477:2026(en)
Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Fifteen minutes after polymerization, remove the specimen and carefully remove any flash by gently abrading
with abrasive paper (7.5.2.3),(7.5.2.3), avoiding touching any other surface.
7.5.3.3 Type 2 class 2 and type 3 materials
For light (385 nm to 515 nm) photopolymerization initiator materials, cover with a glass plate as top plate;
for. For UV (below 385 nm) photopolymerization initiator materials, cover with a quartz plate as top plate.
Cover the bottom plate with the white filter paper, followed by the film, and position the mould upon it.
Prepare the polymer-based crown and veneering material in accordance with the instruction for use and fill
the mould with the polymer-based crown and veneering material, as described in 7.5.3.2.7.5.3.2. Place a
second piece of film on the polymer-based crown and veneering material in the mould. For light
photopolymerization initiator materials cover this with a glass plate; for. For photo-polymerization initiator
materials, cover this with a quartz plate. Apply pressure to displace excess material by means of the clamp.
Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Irradiate the specimen through the top glass or quartz plate, remove both plates and the white filter paper.
Irradiate the specimen from the other side. Fifteen minutes after polymerization, remove the specimen and
carefully remove any flash by gently abrading with abrasive paper (7.5.2.3).(7.5.2.3).
7.5.3.4 Type 2 class 3 materials
Process the material using vat photopolymerization device, cleaning device and post-curing device and
fabricate the test specimens in the required dimension ([bar, >14 mm (length) x× (4,0 ± 0,2) mm (width) x×
(1,2 ± 0,2) mm (height); at least 2 mm longer than the test span,12mm 12 mm) or (bar, >22 mm (length) x×
(2,0 ± 0,2) mm (width) x× (2,0 ± 0,2) mm (height); at least 2 mm longer than the test span, 20mm).20 mm].
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface, using P1000 or finer of abrasive paper.
7.5.3.5 Type 4 materials
Saw or mill the material using saw or computer-aided milling machine and fabricate the test specimens in the
required dimension ([bar, >14 mm (length) x× (4,0 ± 0,2) mm (width) x× (1,2 ± 0,2) mm (height); at least 2
mm longer than the test span, 12mm12 mm) or bar, >22 mm (length) x× (2,0 ± 0,2) mm (width) x× (2,0 ± 0,2)
mm (heights); at least 2 mm longer than the test span, 20mm).20 mm].
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper.
After removing any flash, polish the surface, using P1000 or finer of abrasive paper.
[3]
NOTE See also ISO 5139 ,ISO 5139, Annex A regarding the preparation of test pieces by sawing.
7.5.4 Procedure
For type 1 to type 3 materials: At (24 ± 2) h after the start of the preparation of the test specimens, measure
the width and the height of the test specimens to an accuracy of 0,01 mm.
For type 4 materials: At (7 d ± 4 h) after the start of the preparation of the test specimens, measure the width
and the height of the test specimens to an accuracy of 0,01 mm.
Apply the load at a cross-head speed of (1.,0 ± 0,3) mm/min or at a loading rate of (50 ± 16) N/min until the
specimen fractures. For type 2 class 2 and type 3 materials, the load shall be applied on the first irradiated
surface.
...

PROJET
Norme
internationale
ISO/DIS 10477
ISO/TC 106/SC 2
Médecine bucco-dentaire —
Secrétariat: ANSI
Produits à base de polymères pour
Début de vote:
couronnes et facettes
2025-03-10
Dentistry — Polymer-based crown and veneering materials
Vote clos le:
2025-06-02
ICS: 11.060.10
CE DOCUMENT EST UN PROJET DIFFUSÉ
POUR OBSERVATIONS ET APPROBATION. IL
EST DONC SUSCEPTIBLE DE MODIFICATION
ET NE PEUT ÊTRE CITÉ COMME NORME
INTERNATIONALE AVANT SA PUBLICATION EN
TANT QUE TELLE.
Le présent document est distribué tel qu’il est parvenu du secrétariat
du comité. OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES
FINS INDUSTRIELLES, TECHNOLOGIQUES ET
COMMERCIALES, AINSI QUE DU POINT DE VUE
DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
TRAITEMENT PARALLÈLE ISO/CEN
CONSIDÉRÉS DU POINT DE VUE DE LEUR
POSSIBILITÉ DE DEVENIR DES NORMES
POUVANT SERVIR DE RÉFÉRENCE DANS LA
RÉGLEMENTATION NATIONALE.
LES DESTINATAIRES DU PRÉSENT PROJET
SONT INVITÉS À PRÉSENTER, AVEC LEURS
OBSERVATIONS, NOTIFICATION DES DROITS
DE PROPRIÉTÉ DONT ILS AURAIENT
ÉVENTUELLEMENT CONNAISSANCE
ET À FOURNIR UNE DOCUMENTATION
EXPLICATIVE.
Numéro de référence
ISO/DIS 10477:2025(fr)
ISO/TC 106/SC 2
ISO/DIS 10477:2025(fr)
ƒ–‡ǣʹͲʹͶǦͳͳǦͳͷ
ISO/DIS 10477 :2025(F)
ȀͳͲ͸Ȁʹ
  ‡…”±–ƒ”‹ƒ–ǣ
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Dentistry — Polymer-based crown and veneering materials
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2025
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse

ii
ISO/DIS 10477 :2025(fr)
Sommaire Page
Avant-propos . v
Introduction . vi
1 Domaine d’application .1
2 Références normatives .1
3 Termes et définitions .2
4 Classification .3
5 Exigences .4
5.1 Généralités .4
5.2 Profondeur de polymérisation .4
5.2.1 Généralités .4
5.2.2 Profondeur de polymérisation (uniquement matériaux de type 2 classe 2) .4
5.3 Fini de surface .4
5.4 Résistance à la flexion .5
5.5 Force d’adhésion .5
5.5.1 Système de collage spécial sans rétention macromécanique .5
5.5.2 Valeurs supérieures à 5 MPa .5
5.6 Absorption d’eau .5
5.7 Solubilité .5
5.8 Uniformité de la teinte .6
5.9 Stabilité de la couleur .6
6 Échantillonnage .6
6.1 Pour tous les essais .6
6.2 Pour l’essai d’uniformité de la teinte .6
6.3 Pour l’essai de stabilité de la couleur .6
7 Mesurage et méthodes d’essai .6
7.1 Généralités .6
7.1.1 Conditions d'essai ambiantes .6
7.1.2 Eau .6
7.1.3 Préparation des éprouvettes .7
7.2 Contrôle visuel .7
7.3 Profondeur de polymérisation (uniquement pour le type 2, classe 2 si pas de résine
opaque) .7
7.3.1 Appareillage .7
7.3.2 Matériaux .7
7.3.3 Mode opératoire.8
7.3.4 Expression des résultats .8
7.4 Fini de surface .8
7.4.1 Appareillage (pour matériaux de type 2, classe 3 et type 4) .8
7.4.2 Préparation du spécimen .8
7.4.3 Polissage de surface .9
7.5 Résistance à la flexion . 10
7.5.1 Appareillage . 10
7.5.2 Matériaux . 11
7.5.3 Préparation des éprouvettes . 12
7.5.4 Mode opératoire. 13
7.5.5 Expression des résultats . 13
iii
ISO/DIS 10477 :2025(fr)
7.6 Tenue des liaisons (uniquement type 1, type 2 classes 1 et 2 et matériaux type 3), . 14
7.6.1 Appareillage . 14
7.6.2 Matériaux . 15
7.6.3 Préparation des éprouvettes . 15
7.6.4 Mode opératoire . 16
7.6.5 Expression des résultats . 16
7.7 Absorption d’eau et solubilité . 16
7.7.1 Appareillage . 16
7.7.2 Matériaux . 17
7.7.3 Préparation de l’éprouvette . 18
7.7.4 Mode opératoire . 18
7.7.5 Expression des résultats . 19
7.8 Uniformité de la teinte et stabilité de la couleur . 20
7.8.1 Généralités. 20
7.8.2 Appareillage . 20
7.8.3 Matériaux . 20
7.8.4 Préparation des éprouvettes . 21
7.8.5 Mode opératoire . 21
7.8.6 Comparaison des couleurs . 22
7.8.7 Expression des résultats d’uniformité de la teinte . 22
7.8.8 Expression des résultats de stabilité de la couleur . 22
8 Emballage et étiquetage. 22
8.1 Emballage . 22
8.2 Etiquetage et mode d’emploi . 22
Bibliographie . 26
iv
ISO/DIS 10477 :2025(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en
général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit
de faire partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales
et non gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore
étroitement avec la Commission électrotechnique internationale (IEC) en ce qui concerne la
normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voirwww.iso.org/directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable de
ne pas avoir identifié de tels droits de brevet. Les détails concernant les références aux droits de propriété
intellectuelle ou autres droits analogues identifiés lors de l’élaboration du document sont indiqués dans
l’Introduction et/ou dans la liste des déclarations de brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication sur la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO relatifs à l'évaluation de la conformité, ainsi que des informations sur l'adhésion de
l'ISO aux principes de l'Organisation mondiale du commerce (OMC) dans les obstacles techniques au
commerce (OTC), voir l'URL suivante : www.iso.org/iso/foreword.html.
Le présent document a été élaboré par le Comité technique ISO/TC 106, Médecine bucco-dentaire, sous-
comité SC 2, Produits pour prothèses dentaires, en collaboration le Comité technique CEN/TC 55, Médecine
bucco-dentaire, du Comité européen de normalisation (CEN), conformément à l’Accord de coopération
technique entre l’ISO et le CEN (Accord de Vienne).
Cette cinquième édition annule et remplace la quatrième édition (ISO 10477 :2020), qui a été révisée
techniquement.
Les principales modifications par rapport à l’édition précédente sont les suivantes :
— ajout de documents imprimés à l’Article 4 en tant que Classe 3 de Type 2 ;
— ajout de matériaux fraisés à l’Article 4 en tant que Type 4.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste complète de ces organismes est
disponible sur www.iso.org/members.html.
v
ISO/DIS 10477 :2025(fr)
Introduction
Le présent document ne comporte aucune méthode d’essai qualitative ou quantitative spécifique pour
démontrer l’absence de risques biologiques inacceptables. Il est recommandé de se référer à l’ISO 10993-
1 et à l’ISO 7405 pour l’évaluation des risques biologiques potentiels.
vi
PROJET DE NORME INTERNATIONALE ISO/DIS 10477 :2025(fr)

Médecine bucco-dentaire — Produits à base de polymères
pour couronnes et facettes
1 Domaine d’application
Le présent document établit une classification des produits à base de polymères pour couronnes et
facettes utilisés en médecine bucco-dentaire, et spécifie les exigences qui leur sont applicables. Il spécifie
également les méthodes d’essai à utiliser en vue de la détermination de leur conformité à ces exigences.
Le présent document s'applique aux matériaux de couronne et de placage à base de polymère destinés
aux placages ou couronnes permanents fabriqués en laboratoire. Il s’applique également aux produits à
base de polymères pour couronnes et facettes pour lesquels le fabricant revendique une adhérence à
l’infrastructure sans rétention macromécanique, telle que les billes ou les fils.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s’applique (y compris les
éventuels amendements).
ISO1942, Dentisterie — Vocabulaire
ISO 3696, Eau pour laboratoire à usage analytique — Spécification et méthodes d’essai
ISO6344-2, Abrasifs enrobés — Détermination et désignation de la répartition granulométrique — Partie
2 : Tailles de macrogrit P12 à P220
ISO6344-3, Abrasifs enrobés — Détermination et désignation de la répartition granulométrique — Partie
3 : Tailles de microréseau de P240 à P5000
ISO6507-1, Matériaux métalliques — Essai de dureté Vickers — Partie 1 : Méthode d’essai
ISO 7491, Produits dentaires — Détermination de la stabilité de couleur
ISO7500-1, Matériaux métalliques — Étalonnage et vérification des machines statiques d'essai uniaxiales
— Partie 1 : Machines d'essai de tension/compression — Étalonnage et vérification du système de mesure
de force
ISO8601-1, Date et heure — Représentations pour l'échange d'informations — Partie 1 : Règles de base
ISO18739, Dentisterie — Vocabulaire de la chaîne de processus pour les systèmes CAD/CAM
ISO 22674, Médecine bucco-dentaire — Matériaux métalliques pour les restaurations fixes et amovibles et
les appareillages
ISO/ASTM52900 :2021, Fabrication additive — Principes généraux — Principes fondamentaux et
vocabulaire
ISO/DIS 10477 :2025(fr)
ISO5139, Dentisterie — Ébauches à usiner en composite à base de polymère
3 Termes et définitions
Pour les besoins du présent document, les termes et les définitions de l’ISO 1942 ainsi que les suivants
s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes :
— ISO Online browsing platform: disponible à l'adresse http://www.iso.org/obp
— IEC Electropedia : disponible à l'adresse https://www.electropedia.org/
3.1
produit à base de polymère pour couronnes et facettes
composition de poudres, liquides, pâtes (après polymérisation complète) ou disques ou blocs
polymérisés (déjà polymérisés par le fabricant) pouvant contenir des monomères, des charges
inorganiques et/ou polymères convenant à une utilisation comme facettes ou couronnes dentaires
permanentes
Note 1 à l’article : La polymérisation s’effectue par mélange d’un ou plusieurs initiateurs et d’un ou plusieurs
activateurs (autopolymérisation) et/ou par l’application d’une énergie d’activation extérieure [par la chaleur
(polymérisation thermique), par photoactivation, par activation par la lumière visible (photopolymérisation) et/ou
par un rayonnement ultraviolet].
Note 2 à l’article : Les produits à base de polymères pour couronnes et facettes destinés aux couronnes ou facettes
permanentes fabriquées en laboratoire sont susceptibles ou non d’être fixées à une infrastructure.
3.2
résine dentinaire
produit à base de polymère pour couronnes et facettes (3.1), pigmenté et légèrement transparent, qui
simule l’aspect naturel de la dentine
3.3
résine amélaire
matériau de couronne et de placage à base de polymère translucide et légèrement pigmenté (3.1) qui
simule l’aspect naturel de l’émail
3.4
résine cervicale
produit à base de polymère pour couronnes et facettes (3.1), très pigmenté et légèrement translucide, qui
simule l’aspect naturel de la dentine de la partie cervicale de la dent
3.5
résine opaque
produit à base de polymère pour couronnes et facettes (3.1) très pigmenté, appliqué en couches minces
pour masquer entièrement le matériau sous-jacent et y adhérer
Note 1 à l’article : Les résines opaques doivent uniquement remplir l’exigence de 5.5.
ISO/DIS 10477 :2025(fr)
3.6
broyage
synonyme fabrication soustractive: processus d'usinage, de meulage ou de réduction d'un objet en vrac
plus grand pour créer un objet tridimensionnel détaillé plus petit en utilisant des méthodes CAD/CAM
Note 1 à l’article : Le terme fraisage est utilisé dans le présent document car il s'agit d'un terme courant dans la
technologie dentaire et la dentisterie clinique pour le traitement de ces matériaux.
3.7
impression
fabrication additive synonyme : procédé dans lequel un photopolymère liquide dans une cuve (3.8) est
sélectivement durci par polymérisation activée par la lumière. Le photopolymère liquide peut contenir
des charges.
Note 1 à l’article : Le terme impression est utilisé dans le présent document car il s'agit d'un terme courant dans la
technologie dentaire et la dentisterie clinique pour le traitement de ces matériaux.
3.8
taxe d'entrée
petite cuve, partie du dispositif de polymérisation qui contient le photopolymère liquide.
4 Classification
Les produits à base de polymères pour couronnes et facettes décrits dans le présent document doivent
être classés en fonction de leur système d’activation de la polymérisation :
— Type 1 : matériaux de couronne et de placage à base de polymère dont la prise est effectuée en
mélangeant initiateur(s) et activateur(s) (matériaux « autodurcissables ») ;
— Type 2 : matériaux de couronne et de placage à base de polymère dont la prise en charge est effectuée
par l’application d’énergie provenant d’une source externe (matériaux « activés par l’énergie externe
»), tels que la chaleur et/ou le rayonnement (visible ou UV) ;
— Classe 1 : matériaux de couronne et de placage à base de polymère ne contenant pas d’initiateur
de photo-polymérisation ;
— Classe 2 : matériaux de couronne et de placage à base de polymère qui contiennent un initiateur
de photo-polymérisation et ne sont pas destinés à la fabrication additive (impression) ;
— Classe 3 : matériaux de couronne et de placage à base de polymère destinés à la fabrication
additive (impression) ;
— Type 3 : matériaux de couronne et de placage à base de polymère dont la prise est affectée par le
mélange d’initiateur(s) et d’activateur(s) et également par l’application d’énergie provenant d’une
source externe (matériaux « à double polymérisation ») ;
— Type 4 : matériaux de couronne et de placage à base de polymère destinés à la fabrication
soustractive (fraisage).
ISO/DIS 10477 :2025(fr)
5 Exigences
5.1 Généralités
Les essais exigés pour un produit pour couronnes et facettes dépendent de la classification de ce dernier
(type et classe).
Voir le Tableau 1 pour les indications sur la nécessité de réaliser les essais spécifiques décrits de 5.2 à 5.9.
Tableau 1 — Protocole d’essai
Paragraphe Propriété Type 1 Type 2 Type 3 Type 4
Classe 1 Classe 2 Classe 3
a b
5.2 Profondeur de — — + — — —
polymérisation
a a a a
5.3 Fini de surface + + + + + +
a a a a
5.4 Résistance à la + + + + + +
flexion
c c
5.5 Solidité du lien avec + + + - + -
la charpente
a a a a
5.6 à 5.9 Absorption d’eau, + + + + + +
solubilité, uniformité
de la teinte, stabilité
de la couleur
Légende
+ Réaliser l’essai.
— ne pas soumettre à essai ;
a
Si le matériau est de la résine opaque, ne pas effectuer de test ;
b
Non exigé car partie fixe du processus d’impression ;
c
Non exigé car ces matériaux ne sont pas destinés à la facette.
5.2 Profondeur de polymérisation
5.2.1 Généralités
L’essai doit être réalisé conformément à 7.3.
5.2.2 Profondeur de polymérisation (uniquement matériaux de type 2 classe 2)
Pour les matériaux de type 2 classe 2, la dureté de la surface inférieure ne doit pas être inférieure à 70 %
de celle de la surface supérieure (voir Tableau 2).
Aucune exigence n'est spécifiée pour les matériaux de type 1, de type 2 et de type 3 et de type 4. Cette
exigence n’est pas applicable aux résines opaques.
Pour les matériaux de classe 3 de type 2, aucune exigence n'est spécifiée car le processus de durcissement
est intrinsèquement défini dans le processus d'impression.
5.3 Fini de surface
La surface d’une éprouvette polie conformément à 7.4 doit être brillante.
L’essai doit être réalisé conformément à 7.4. Cette exigence n’est pas applicable aux résines opaques.
ISO/DIS 10477 :2025(fr)
5.4 Résistance à la flexion
La résistance à la flexion doit être au moins de 50 MPa pour les classes 1 et 2 de type 1 et de type 2 et de
type 3, et au moins de 80 MPa pour les matériaux de classe 3 de type 2 et de type 4 (voir Tableau 2). Cette
exigence n’est pas applicable aux résines opaques.
L’essai doit être réalisé conformément à 7.5.
Tableau 2 — Exigences relatives aux propriétés physiques et chimiques
Paragraphe Propriété Exigence
5.2 Profondeur de Dureté de la surface inférieure ≥ 70 % de celle de
polymérisation la surface supérieure
Résistance à la flexion ≥ 50 MPa pour les classes 1 et 2 de type 1 et 2

et de type 3
5.4
≥ 80 MPa pour la classe de type 2 3 et le type 4
5.5.1 Force d’adhésion ≥ 5 MPa
≥ 80 % de la valeur revendiquée mais ≥ 5 MPa
5.5.2
5.6 Absorption d’eau ≤ 40 µg/mm
5.7 Solubilité ≤ 7,5 µg/mm
5.5 Force d’adhésion
5.5.1 Système de collage spécial sans rétention macromécanique
Si le fabricant recommande un système de collage spécial sans rétention macromécanique, la force
d’adhésion au matériau d’infrastructure ne doit pas être inférieure à 5 MPa (voir Tableaux 1 et 2).
L’essai doit être réalisé conformément à 7.6.
5.5.2 Valeurs supérieures à 5 MPa
Si le fabricant revendique une valeur supérieure à 5 MPa pour la résistance de la liaison, celle-ci ne doit
pas être inférieure à 80 % de la valeur revendiquée avec un minimum de 5 MPa.
L’essai doit être réalisé conformément à 7.6.
5.6 Absorption d’eau
L’absorption d’eau par les produits pour couronnes et facettes polymérisés ne doit pas dépasser
40 µg/mm (voir Tableau 2).
L’essai doit être réalisé conformément à 7.7. Cette exigence n’est pas applicable aux résines opaques.
5.7 Solubilité
La solubilité dans l’eau des produits pour couronnes et facettes polymérisés ne doit pas être supérieure
à 7,5 µg/mm (voir Tableau 2).
L’essai doit être réalisé conformément à 7.7. Cette exigence n’est pas applicable aux résines opaques.
ISO/DIS 10477 :2025(fr)
5.8 Uniformité de la teinte
La couleur des produits pour couronnes et facettes polymérisés issus de lots différents (selon 6.1 et 6.2)
ne doit présenter qu’une faible différence par rapport à la couleur indiquée par le fabricant.
L’essai doit être réalisé conformément à 7.8 et à l’ISO 7491. Cette exigence n’est pas applicable aux résines
opaques.
5.9 Stabilité de la couleur
Les produits à base de polymères pour couronnes et facettes ne doivent présenter qu’une faible variation
de couleur.
L’essai doit être réalisé conformément à 7.8 et à l’ISO 7491. Cette exigence n’est pas applicable aux résines
opaques.
6 Échantillonnage
6.1 Pour tous les essais
L’échantillon d'essai doit être constitué d'un ou plusieurs boîtiers d'une nuance choisie, correspondant à
l'objectif de l'essai, provenant d'un seul lot et contenir suffisamment de matériau pour réaliser les essais
spécifiés, plus une tolérance pour toute répétition nécessaire des essais.
NOTE Pour les matériaux de type 1, de type 2, classes 1 et 2, et de type 3, environ 20 ml de matériau peuvent être
nécessaires.
6.2 Pour l’essai d’uniformité de la teinte
L’échantillon pour le test de cohérence de la teinte (5.8 et 7.8) doit être constitué de la même teinte qu’en
6.1, mais provenant d’un autre lot.
NOTE Pour les matériaux de type 1, de type 2, classes 1 et 2, et de type 3, environ 1 ml de matériau sera
nécessaire.
6.3 Pour l’essai de stabilité de la couleur
L’échantillon pour l’essai de stabilité de la couleur (5.9 et 7.8) doit comprendre deux autres teintes du
produit. La teinte de l’échantillon de résine doit être constituée de trois teintes différentes, chacune
correspondant à une teinte représentative de résine d’émail, de résine de dentine et de résine cervicale.
Il convient de les sélectionner en fonction de leurs colorants, si différents colorants sont utilisés.
NOTE Pour les matériaux de type 1, de type 2, classes 1 et 2, et de type 3, environ 1 ml de matériau sera
nécessaire.
7 Mesurage et méthodes d’essai
7.1 Généralités
7.1.1 Conditions d'essai ambiantes
Les essais doivent être réalisés dans les conditions ambiantes (23 ± 2) °C et (50 ± 20) % d'humidité
relative.
7.1.2 Eau
Sauf spécification contraire, l’eau utilisée doit être conforme à l’ISO 3696 :1987, qualité 3.
ISO/DIS 10477 :2025(fr)
7.1.3 Préparation des éprouvettes
Pour la préparation des matériaux de recouvrement et de placage à base de polymères de type 2 et de
type 3, il doit être fait référence aux instructions d'utilisation indiquant la ou les sources d’énergie
externes recommandées pour les matériaux à soumettre à essai. Il faut veiller à ce que la source d’énergie
soit parfaitement opérationnelle.
Mélanger ou préparer d’une autre manière le produit à base de polymère pour couronnes et facettes
conformément aux instructions d’utilisation et aux conditions d’essai spécifiées en 7.1.1.
N’utiliser que la quantité exigée pour la préparation de l’une des éprouvettes correspondantes.
Si des spécimens entièrement durcis sont exigés pour les essais (7.4 à 7.8), il est important de s'assurer
que les spécimens sont homogènes. Elles ne doivent présenter aucune soufflure, fissure ou inclusion d’air
repérable à l’examen visuel sans grossissement.
Un agent de séparation qui n’interfère pas avec la réaction de prise, par exemple une solution à 3 % de
cire de polyvinylstéaryle éther dans de l’hexane, peut être utilisé pour faciliter le retrait de l’éprouvette
du moule.
Impression (matériaux de type 2, classe 3))
Imprimer et traiter la couronne et le matériau de placage à base de polymère conformément aux
instructions d'utilisation.
Fraisage (matériaux de type 4)
Fraiser conformément aux instructions d'utilisation ou scier la couronne et le matériau de placage à base
de polymère ou la couronne et le matériau de placage à base de polymère de manière similaire, en prenant
soin d'éviter la génération excessive de chaleur
7.2 Contrôle visuel
Effectuer un examen visuel pour déterminer la conformité à l'Article 8. La comparaison des couleurs
de 7.8 doit être réalisée conformément à l’ISO 7491.
7.3 Profondeur de polymérisation (uniquement pour le type 2, classe 2 si pas de résine
opaque)
7.3.1 Appareillage
7.3.1.1 Bagues fendues telles que représentées à la Figure 1, de diamètre (15 ± 1) mm et de hauteur
(1,0 ± 0,1) mm.
7.3.1.2 Deux plaques, p. ex. métal ou verre poli, mesurant environ 20 mm × 20 mm × 5 mm.
7.3.1.3 Source de rayonnement, selon les recommandations du mode d’emploi.
7.3.1.4 Instrument d'essai de dureté, pour HV 0,5.
7.3.1.5 Four, régler à (37 ± 1) °C.
7.3.2 Matériaux
7.3.2.1 Papier filtre blanc.
7.3.2.2 Film, incolore, transparent, épaisseur de (50 ± 30) μm.
7.3.2.3 Composé de polissage, carbonate de calcium précipité (CaCO ).
ISO/DIS 10477 :2025(fr)
7.3.2.4 Roue en mousseline, non cousue, 18 à 36 plis, d'un diamètre de 70 mm à 95 mm.
7.3.3 Mode opératoire
7.3.3.1 Préparation du spécimen
Couvrir une plaque (7.3.1.2) avec un morceau de papier filtre blanc (7.3.2.1) puis avec le film (7.3.2.2) et
placer le moule annulaire fendu (7.3.1.1) par-dessus. Préparer le produit à base de polymère pour
couronnes et facettes conformément aux instructions d’utilisation et en garnir le moule annulaire fendu
jusqu’à léger débordement. Recouvrir le produit et le moule d’un second morceau de film et de l’autre
plaque (7.3.1.2) ; retirer l’excès de produit. Retirer la plaque supérieure et exposer l’éprouvette dans le
moule annulaire fendu au rayonnement à travers le film, conformément aux instructions d’utilisation.
Sortir l’éprouvette du moule annulaire fendu.
Préparer trois éprouvettes et les stocker dans de l'eau à (37 ± 1) °C pendant (24 ± 2) h. Effectuer l'essai
de dureté sur les surfaces supérieure et inférieure des éprouvettes trois fois conformément à l'ISO6507-
1.
7.3.4 Expression des résultats
Exprimer la dureté de chaque surface par la moyenne des trois valeurs obtenues.
Les trois éprouvettes doivent satisfaire à l’exigence de 5.2. Dans le cas contraire, le produit à base de
polymère pour couronnes et facettes n’est pas conforme à l’exigence de 5.2.
7.4 Fini de surface
7.4.1 Appareillage (pour matériaux de type 2, classe 3 et type 4)
7.4.1.1 dispositif de photopolymérisation à cuve (pour la classe 3 de type 2), tel que recommandé
dans le mode d'emploi.
7.4.1.2 Dispositif de nettoyage (pour le type 2, classe 3), pour éliminer le monomère n'ayant pas
réagi comme recommandé dans le mode d'emploi.
7.4.1.3 Dispositif de post-polymérisation (pour la classe 3 de type 2), tel que recommandé dans le
mode d'emploi.
7.4.1.4 Fraiseuse (pour le type 4), selon les recommandations du mode d'emploi.
7.4.1.5 Papier abrasif, à P220 ou P320 conformément à l'ISO6344-2.
7.4.1.6 Papier abrasif, au moins P1000 conformément à l'ISO6344-2.
7.4.2 Préparation du spécimen
Pour les matériaux de type 1, de type 2, des classes 1 et 2 et de type 3, préparer un spécimen
conformément à 7.3.3. Polir l’éprouvette préparée conformément aux instructions d’utilisation. Si aucun
mode opératoire spécifique n’est indiqué, polir l’éprouvette conformément aux instructions fournies
en 7.4.3.
Pour les matériaux de type 2, classe 3 Fabriquer le spécimen dans les dimensions exigées (spécimen
rond, diamètre (15 ± 1) mm, hauteurs (1,0 ± 0,1) mm ou spécimen de forme carrée, (13 ± 1) mm, hauteurs
(1,0 ± 0,1) mm.
Enlever les supports et éliminer avec précaution les éclats en les abritant délicatement avec du papier
abrasif P220 ou P320 (7.4.1.4).
ISO/DIS 10477 :2025(fr)
Après avoir enlevé tout flash, polir la surface à l'aide de P1000/P2000 de papier abrasif (7.4.1.5)
Pour les matériaux de type 4, fraiser ou scier le spécimen dans les dimensions exigées (spécimen rond,
diamètre (15 ± 1) mm, hauteurs (1,0 ± 0,1) mm ou spécimen de forme carrée, (13 ± 1) mm, hauteurs (1,0
± 0,1) mm.
Enlever les supports et éliminer avec précaution les éclats en les abritant délicatement avec du papier
abrasif P220 ou P320 (7.4.1.4).
Après avoir enlevé tout flash, polir la surface à l'aide de P1000/P2000 de papier abrasif (7.4.1.5)
7.4.3 Polissage de surface
Rectifier (sous irrigation d’eau) les deux faces de l’éprouvette et polir celle-ci conformément aux
instructions d’utilisation. Si aucun mode opératoire spécifique n’est indiqué, polir l’éprouvette pendant
une durée maximale de 1 min au moyen d’un disque en feutre (7.3.2.4), à une vitesse circonférentielle de
(650 ± 350) m/min, et d’un agent de polissage (7.3.2.3). Maintenir une distance d’au moins 10 mm entre
le diamètre extérieur du disque et la jointure ou tout autre renfort.
Nettoyer soigneusement le spécimen en rinçant à l'eau, sécher par tamponnage et inspecter visuellement
la surface. Si la surface du spécimen est brillante lors de l'examen visuel. le matériau de placage à base de
polymère est conforme aux exigences du paragraphe 5.3.
NOTE Une roue de 70 mm de diamètre tournant à 1 500 tr/min a une vitesse circonférentielle de 330 m/min et
une roue de 100 mm de diamètre tournant à 3 500 tr/min a une vitesse circonférentielle de 1 100 m/min.
Dimensions en millimètres
ISO/DIS 10477 :2025(fr)
Légende
1 plaques en métal ou en verre
2 moule annulaire fendu
3 plaque de support
Figure 1 — Moule pour la préparation des éprouvettes pour les essais de profondeur de
polymérisation, de fini de surface, d’absorption d’eau, de solubilité, d’uniformité de la teinte et
de stabilité de la couleur
7.5 Résistance à la flexion
7.5.1 Appareillage
7.5.1.1 Moule en acier inoxydable fendu (pour les matériaux de type 1, de type 2 classes 1 et 2, et de
type 3), revêtu d'un milieu séparateur (par exemple, solution à 3 % de cire d'éther de polyvinylstéaryle
dans de l'hexane), comme représenté à la Figure 2, dans un dispositif de montage approprié.
7.5.1.2 Deux plaques de verre ou de métal (pour les matériaux de type 1, de type 2 classes 1 et 2 et de
type 3), d’environ 30 mm × 30 mm × 2 mm.
ISO/DIS 10477 :2025(fr)
7.5.1.3 Petit collier à vis (pour matériaux de type 1, de type 2 classes 1 et 2, et de type 3).
7.5.1.4 Appareillage de polymérisation (pour les classes 1 et 2 de type 2 et les matériaux de type 3),
tel que recommandé dans la notice d'utilisation.
7.5.1.5 dispositif de photopolymérisation à cuve (pour la classe 3 de type 2), tel que recommandé
dans le mode d'emploi.
7.5.1.6 Dispositif de nettoyage (pour le type 2, classe 3), pour éliminer le monomère n'ayant pas
réagi comme recommandé dans le mode d'emploi.
7.5.1.7 Dispositif de post-polymérisation (pour la classe 3 de type 2), tel que recommandé dans le
mode d'emploi.
7.5.1.8 Fraiseuse (pour le type 4), selon les recommandations du mode d’emploi.
7.5.1.9 Scie (facultative) adaptée à la découpe de matériau de type 4
7.5.1.10 Four, régler à (37 ± 1) °C.
7.5.1.11 Appareil d'essai de résistance à la flexion, étalonné conformément à l'ISO 7500-1, pour
fournir une vitesse constante de la tête transversale de (1,0 ± 0,3) mm/min. L'appareillage se compose
de deux tiges (2 mm de diamètre) montées parallèlement à 12 mm (conformément à l'ISO 5139) entre
les centres, et d'une troisième tige (2 mm de diamètre) centrée entre et parallèle aux deux autres, de sorte
que les trois tiges combinées puissent être utilisées pour appliquer une charge de trois points au
spécimen. D’autres appareils à vitesse de mise en charge constante égale à (50 ± 16) N/min peuvent
également être utilisés.
7.5.1.12 Micromètre, avec une précision de 0,01 mm.
7.5.1.13 Temporisateur, précis à ±1 s.
7.5.2 Matériaux
7.5.2.1 Papier filtre blanc, comme en 7.3.2.1.
7.5.2.2 Film, comme en 7.3.2.2.
7.5.2.3 Papier abrasif, P 2000 selon ISO6344-2.
7.5.2.4 Plaques de métal ou de verre, 1 plaque de quartz pour matériau photo-initié par UV, d’au moins
30 mm × 10 mm × 2 mm.
7.5.2.5 Eau, conforme à ISO3696, Grade 2.
Dimensions en millimètres
ISO/DIS 10477 :2025(fr)
Figure 2 — Moule fendu pour éprouvettes d'essai pour l'essai de flexion des matériaux de type 1,
de type 2 classes 1 et 2 et de type 3
7.5.3 Préparation des éprouvettes
Préparer cinq échantillons conformément à 7.5.3.1 à 7.5.3.4. Après préparation, stocker le spécimen dans
l'eau (7.5.2.5) à (37 ± 1) °C (7.5.1.10) jusqu'au début de l'essai (7.5.4). Les faces inférieures et supérieures
des éprouvettes doivent être parallèles pour l’essai de résistance à la flexion.
7.5.3.1 Matériaux de classe 1 de type 1 et de type 2
Couvrir l’une des plaques en métal ou en verre (7.5.1.2) de film (7.5.2.2) et placer le moule (7.5.1.1) par-
dessus. Préparer le produit à base de polymère pour couronnes et facettes conformément aux
instructions d’utilisation et en garnir immédiatement le moule jusqu’à léger débordement. Recouvrir d’un
second morceau de film et de l’autre plaque en métal ou en verre. Retirer l’excès de produit en appuyant
à l’aide du serre-joint (7.5.1.3).
Polymériser le produit à base de polymère pour couronnes et facettes conformément aux instructions
d’utilisation. Quinze minutes après polymérisation, sortir l’éprouvette du moule et éliminer avec soin au
papier abrasif (7.5.2.3) les bavures éventuelles en évitant de toucher toute autre surface.
7.5.3.2 Matériaux Type 2 classe 2 et Type 3
Pour les matériaux initiateurs de photo-polymérisation légers (385 nm à 515 nm), couvrir avec une
plaque de verre comme plaque supérieure ; pour les matériaux initiateurs de photo-polymérisation UV
(en dessous de 385 nm), couvrir avec une plaque de quartz comme plaque supérieure.
Couvrir la plaque du dessous du papier filtre blanc (7.5.2.1), puis du film (7.5.2.2) et placer le
moule (7.5.1.1) par-dessus. Préparer le produit à base de polymère pour couronnes et facettes
conformément aux instructions d’utilisation et en garnir le moule comme décrit en 7.5.3.1. Recouvrir d’un
second morceau de film. Pour les produits avec initiateurs de photopolymérisation qui réagissent à la
lumière visible, couvrir l’ensemble d’une plaque en verre ; pour les produits avec initiateurs de
photopolymérisation, couvrir l’ensemble avec une plaque en quartz. Retirer l’excès de produit en
appuyant à l’aide du serre-joint (7.5.1.3).
Polymériser le produit à base de polymère pour couronnes et facettes conformément aux instructions
d’utilisation. Irradier le spécimen à travers la plaque supérieure en verre ou en quartz, retirer les deux
ISO/DIS 10477 :2025(fr)
plaques et le papier filtre blanc. Exposer au rayonnement l’autre face de l’éprouvette. Quinze minutes
après polymérisation, sortir l’éprouvette du moule et éliminer avec soin au papier abrasif (7.5.2.3) les
bavures éventuelles.
7.5.3.3 Matériaux de type 2 classe 3
Imprimer et traiter le matériau dans les dimensions exigées (barre, > 14 mm (longueur) x 4,0 ± 0,2 mm
(largeur) x h 1,2 ± 0,2 mm (hauteurs); au moins 2 mm plus long que la portée de l'essai).
Enlever les supports et éliminer avec précaution les éclats en les abritant délicatement avec du papier
abrasif (7.5.2.3).
7.5.3.4 Matériaux de type 4
Scier ou fraiser le matériau dans la dimension exig
...