SIST EN ISO 10477:2026
(Main)Dentistry - Polymer-based crown and veneering materials (ISO 10477:2026)
General Information
- Abstract
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.
- Status
- Published
- Public Enquiry End Date
- 30-May-2025
- Publication Date
- 29-Sep-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 24-Sep-2026
- Due Date
- 29-Nov-2026
- Completion Date
- 30-Sep-2026
Overview
SIST EN ISO 10477:2026 is an international standard that sets the classification and requirements for polymer-based crown and veneering materials used in dentistry. The standard, developed by the Slovenski inštitut za standardizacijo (SIST) in alignment with ISO 10477:2026, ensures that polymer-based dental materials for crowns and permanent veneers meet industry benchmarks. This document specifies not only material requirements but also detailed test methods for evaluating properties such as mechanical strength, color stability, and adhesion.
By establishing uniform criteria for these polymer-based dental materials, the standard supports dental laboratories, manufacturers, and clinics in delivering reliable, safe, and aesthetically pleasing restorations.
Key Topics
Classification of Materials:
- Type 1: Self-curing
- Type 2: External energy-activated (e.g., heat, light)
- Type 3: Dual-cure (initiation by both mixing and external energy)
- Type 4: Materials for subtractive manufacturing (milling)
- Classes 1 to 3 distinguish materials by photoinitiator content and intended use (e.g., for printing).
Performance Requirements:
- Depth of Cure: Assesses how well the material hardens throughout its thickness.
- Flexural Strength: Measures ability to withstand bending forces - ensuring long-term durability.
- Bond Strength: Validates adhesion to substructures without macromechanical retention (e.g., beads or wires).
- Water Sorption and Solubility: Ensures material stability and resistance to degradation in the oral environment.
- Shade Consistency & Colour Stability: Maintains aesthetic quality over time and between production batches.
- Surface Finish: Specifies polishing and finishing standards for laboratory-fabricated restorations.
Testing Methods:
The document outlines detailed, repeatable methods for each property, ensuring consistent test conditions and reliable comparison of materials across manufacturers.
Applications
Dental Laboratories:
Use the standard to select, evaluate, and validate laboratory-fabricated polymer-based crowns and veneers against international benchmarks. Following the requirements ensures high material quality and clinical performance.Material Manufacturers:
Apply the test methods and performance thresholds during research, development, and production. This facilitates market access, regulatory compliance, and customer assurance.Dental Clinics:
Benefit from restorations manufactured with compliant polymer-based materials, offering confidence in strength, color stability, and long-term function for patients.Regulatory and Procurement:
Provides an objective basis for specifying and approving dental materials in tenders, procurement, and regulatory submissions.
Related Standards
- ISO 10993-1: Biological evaluation of medical devices - Guidance for assessing biocompatibility, essential for dental material safety.
- ISO 7491: Dental materials - Determination of colour stability, referenced for color testing procedures.
- ISO 6507-1: Metallic materials - Vickers hardness test, used in depth of cure assessment.
- ISO 3696: Water for analytical laboratory use - Ensures water quality in testing protocols.
- ISO 5139 & ISO/ASTM 52900: Standards on polymer-based machinable blanks and additive manufacturing, relevant for CAD/CAM and 3D printed dental materials.
Practical Value
SIST EN ISO 10477:2026 plays a vital role in ensuring that polymer-based dental crown and veneering materials consistently meet international quality standards. This underpins reliable performance, aesthetics, and patient satisfaction in dental restorations. Clear classification and rigorous testing help harmonize product development and support the global dental materials market.
Keywords: polymer-based dental materials, crown and veneering materials, dental laboratory standards, ISO 10477, flexural strength, colour stability, dental restorations, laboratory-fabricated crowns, dental materials testing, dental standards compliance
Relations
- Replaces
SIST EN ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020) - Effective Date
- 01-Nov-2026
- Effective Date
- 17-Sep-2026
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Frequently Asked Questions
SIST EN ISO 10477:2026 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Polymer-based crown and veneering materials (ISO 10477:2026)". This standard covers: 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.
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.
SIST EN ISO 10477:2026 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 10477:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10477:2020, SIST EN 1641:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 10477:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2026
Nadomešča:
SIST EN ISO 10477:2020
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2026)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2026)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2026)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO 10477:2026)
Ta slovenski standard je istoveten z: EN ISO 10477:2026
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10477
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2026
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10477:2020
English Version
Dentistry - Polymer-based crown and veneering materials
(ISO 10477:2026)
Médecine bucco-dentaire - Produits à base de Zahnheilkunde - Polymerbasierte Kronen- und
polymères pour couronnes et facettes (ISO Verblendwerkstoffe (ISO 10477:2026)
10477:2026)
This European Standard was approved by CEN on 18 July 2026.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10477:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2027, and conflicting national standards shall
be withdrawn at the latest by March 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10477:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10477:2026 has been approved by CEN as EN ISO 10477:2026 without any modification.
International
Standard
ISO 10477
Fifth edition
Dentistry — Polymer-based crown
2026-09
and veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Reference number
ISO 10477:2026(en) © ISO 2026
ISO 10477:2026(en)
© ISO 2026
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10477:2026(en)
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
ISO 10477:2026(en)
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
ISO 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:
— 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
ISO 10477:2026(en)
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
International Standard ISO 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
ISO 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) 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.
ISO 10477:2026(en)
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.
ISO 10477:2026(en)
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
additive manufacturing 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.
ISO 10477:2026(en)
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.
ISO 10477:2026(en)
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.
ISO 10477:2026(en)
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.
ISO 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.
ISO 10477:2026(en)
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].
ISO 10477:2026(en)
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 f
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