FprCEN/TR 12401

Dentistry - Guidance on the classification of dental devices and accessories

This document provides guidance on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.

Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehör

Médecine bucco‐dentaire - Recommandations relatives à la classification des dispositifs dentaires et accessoires

Le présent Rapport technique du CEN fournit des recommandations concernant l’application des règles de classification établies dans le Règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux dans la mesure où ces règles s’appliquent aux dispositifs dentaires et à leurs accessoires.

Zobozdravstvo - Napotki za razvrščanje zobozdravstvenih naprav in pripomočkov

General Information

• Status: Not Published
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55/WG 3 - Classification
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 19-Jan-2023
• Due Date: 26-Oct-2022
• Completion Date: 19-Jan-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Ref Project: kSIST-TP FprCEN/TR 12401:2023 - Dentistry - Guidance on the classification of dental devices and accessories

Relations

• Revises: CEN/TR 12401:2009 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 07-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 12401:2023
01-januar-2023
Zobozdravstvo - Napotki za razvrščanje zobozdravstvenih naprav in pripomočkov
Dentistry - Guidance on the classification of dental devices and accessories
Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehör

Médecine bucco‐dentaire - Recommandations relatives à la classification des dispositifs

dentaires et accessoires
Ta slovenski standard je istoveten z: FprCEN/TR 12401
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
kSIST-TP FprCEN/TR 12401:2023 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TP FprCEN/TR 12401:2023
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kSIST-TP FprCEN/TR 12401:2023
FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 12401
RAPPORT TECHNIQUE
TECHNISCHER REPORT
October 2022
ICS 11.060.01
English Version
Dentistry - Guidance on the classification of dental devices
and accessories

Médecine bucco-dentaire - Recommandations relatives Zahnheilkunde - Anleitung zur Klassifizierung von

à la classification des dispositifs dentaires et Dentalprodukten und Zubehör
accessoires

This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC 55.

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.

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.

Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 12401:2022 E

worldwide for CEN national Members.
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Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 Classification of dental devices and accessories .................................................................................. 5

5 Invasive devices ............................................................................................................................................... 5

5.1 Basic overview ................................................................................................................................................. 5

5.2 Examples for invasive devices .................................................................................................................... 8

6 Non-invasive devices .................................................................................................................................. 15

6.1 Basic overview .............................................................................................................................................. 15

6.2 Examples for non-invasive devices ........................................................................................................ 15

7 Instruments .................................................................................................................................................... 16

7.1 Basic overview .............................................................................................................................................. 16

7.2 Examples for instruments ......................................................................................................................... 16

8 Equipment ...................................................................................................................................................... 19

8.1 Basic overview .............................................................................................................................................. 19

8.2 Example for equipment .............................................................................................................................. 20

Bibliography ................................................................................................................................................................. 22

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European foreword

This document (FprCEN/TR 12401:2022) has been prepared by Technical Committee CEN/TC 055

“Dentistry”, the secretariat of which is held by DIN.
This document is currently submitted to the Vote on TR.

The responsible working group is CEN/TC 55/WG 3 "Classification" (secretariat: DIN), representing the

dental trade and industry, the dental profession and notified bodies.
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Introduction

Dental products are marketed for long term, short term and transient use in the mouth. A large number

of items have been developed to assist in the treatment and prevention of oral diseases and the handling

of dental materials. In contrast to pharmaceuticals (medicinal products), many dental materials are

intended to perform as implanted devices in the oral cavity with a minimum of degradation and release

of substances, i.e. their main action is to replace lost and defective teeth and oral tissue. Some materials

contain elements that may initiate toxic or allergic responses. Other materials have additions of medicinal

substances.

Many dental materials, instruments, equipment and disposables are covered by the Regulation (EU)

2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. The

Regulation also provides rules for the classification of medical devices based on risk and intended use. It

is the manufacturer’s responsibility to classify the product according to the rules of the Regulation.

It is important that the classification is acceptable to Notified Bodies (NB) and Competent Authorities

(CA). The Regulation describes procedures for resolving any disputes over classification between

manufacturers, Notified Bodies and Competent Authorities.

The Medical Device Coordination Group (MDCG) has prepared a document, MDCG 2021-24 "Guidance on

classification of medical devices". This document is intended to complement that guidance. It will,

therefore, be of value to manufacturers in making decisions with regard to the likely classification of

particular devices.
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1 Scope

This document provides guidance on the application of the classification rules in Regulation (EU)

2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as

they pertain to dental devices and accessories.
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.

EN ISO 1942, Dentistry — Vocabulary (ISO 1942)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in EN ISO 1942 apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
4 Classification of dental devices and accessories

The list of dental devices and accessories given in Tables 1 to 5 is not exhaustive. The classification is

based on the most commonly accepted form and intended use of the devices and accessories listed. If a

manufacturer proposes another intended use, the classification of the product may need to be

reconsidered.

Materials and other prefabricated devices that will be part of a custom made device are included in this

guidance document. Custom made devices are not. Some materials can be used both for long term and

short term custom made devices. The intended purpose claimed by the manufacturer will then be

decisive for the classification. In this document, the implementing rule 3.5 of the Regulation has been

used for the proposed classification, i.e. ”the strictest rules.............shall apply”.

This list is intended to be considered in conjunction with the Regulation 2017/745 EU [1] and MDCG

2021-24 "Guidance on classification of medical devices" [2] as prepared by the Medical Device

Coordination Group (MDCG).
Classifications of dental devices and accessories are given in Tables 1 to 5.
5 Invasive devices
5.1 Basic overview
Table 1 — Invasive devices used in the oral cavity
Intended use Rule Class
Long term use (more than 30 days)
Plastic materials for direct insertion 8 II A
metals
polymers
cements
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Intended use Rule Class
Cavity lining materials 8 II A
Dentine adhesives 8 II A
Pit and fissure sealants 5 II A
Protective film (long term) 5 II A
Pulp capping materials 8 II A
non medicated 13 III
medicated
Endodontic filling materials 8 II A
sealers
points
retrograde root canal filling materials
Luting materials 8 II A
water based cements
eugenol based cements
polymer based cements
Materials for fixed prostheses and inlays 8 II A
metals
ceramics and glass
polymers

Materials for removable prostheses and other intraoral appliances including 5 II A

maxillofacial prostheses
metals
ceramics
polymers
Endostabilizers / Transendodontic implants 8 II B

Prefabricated parts, surgically invasive, transient, short term or long term 6,7,8 II A

use (e.g. pins, posts, attachments)
Orthodontic materials and devices, intraoral use 5 II A
metals
ceramics
polymers
Dental implants 8 II B
metals
ceramics and glass
polymers
carbon based
calcium based
Dental implants, biologically active coating 8 III
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Intended use Rule Class
Bone substitutes 8 II B
non resorbable 8 III
resorbable
Materials for guided tissue regeneration 8 II B
non resorbable 8 III
resorbable
Osteo-synthesis devices 8 III
Short term use (max. 30 days)
Protective films (varnish) 5 I
Protective films, medicated 13 III
NOTE 1 Films with a primary function of slow release of medicines are a
medicinal product.
Temporary filling materials 7 II A
Temporary crowns and bridges 7 II A
prefabricated
materials for custom made temporary devices
Short term relining and tissue conditioning materials 5 I
non medicated 13 III
medicated
Surgical packs (dressings) 7 II A
Surgical packs, medicated 13 III
Suture material, non absorbable 7 II A
Suture material, absorbable/medicated 13 III
Transient use (less than 60 min)
Syringe tips for delivery of dental materials 5 I
Materials for surface preparation (etch, prime) 6 II A
Bleaching agents for intra dental bleaching professional use only 6 II A
Impression materials 5 I
Rubber dam and accessories 5 I
Cotton rolls, gaze, etc. 5 I
Wedges 5 I
Waxes 5 I
Gingival retraction device 5 I
Gingival retraction device, medicated 13 III
NOTE 2 Astringents and haemostatic solutions are medicinal products.
Matrix bands 5 I
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Intended use Rule Class
Impression trays 5 I
Endodontic absorbant points 6 II A
Polishing paste 5 I
Polishing paste, medicated 13 III
Polishing strips 5 I
Articulating, occlusion and bite registration devices 5 I
Radiographic devices 16 II A
Table 2 — Invasive devices used in the oral cavity by the patient
Intended use Rule Class
Long term use (more than 30 days)
Cushions and relining materials 5 II A
Short term use (max. 30 days)
Trays for gels 5 I
Temporary filling 6 II A
Denture adhesives, cushions and relining materials 5 I
5.2 Examples for invasive devices
Product description Class Rule Comments
Applications syringes/cannulas I Rule 5 Invasive (e.g. for impression
materials)
IIa Rule 6
Surgically-invasive (e.g. for
cements)
Amalgam IIa Rule 8 Placed in the teeth
Articulation and occlusion I Rule 5 If nanomaterial is present
materials
IIa Rule 19
Bite registration materials I Rule 5 if nanomaterial is present
IIa Rule 19
Bleaching materials for tooth IIa Rule 6 and Rule 7 Content of peroxide >6%
whitening
Rule 19 If nanomaterial is present,
potential for internal
exposure of nanomaterials is
negligible
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Product description Class Rule Comments
Drill sleeves, stop sleeves I Rule 5, Products are used for
transient use of X-ray
first part of
verification of prosthetic
sentence
requirements and for guiding
surgical instruments. Invasive
use in natural body openings.
Arcs, orthodontic IIa Rule 5, Long-term use
3 Indent
Brackets IIa Rule 5 Long-term use
Calcium hydroxide, IIa Rule 8
Calcium salicylate,
Calcium sulfate
Expansion screws IIa Rule 5, 3 Indent Long-term use
Dental implants and abutments IIb Rule 8 Long-term use, not placed “in
the teeth”, therefore not Class
IIa
Dental implants, biological coated III Rule 8 If biological action is claimed
3 Indent
Desensitizer I Rule 5 For transient use
I 1 Indent For short-term use in the oral
cavity
Rule 5
second Indent
Wires, orthodontic (wires, IIa Rule 5, Long-term use
orthodontic arcs for rd
3 Indent
orthodontics)
Excavator, dental Ir Rule 6 Surgical invasive instrument,
reprocessable
Pit and fissure sealant IIa Rule 5 or
Rule 8
Filling materials (composite, IIa Rule 8 if nanomaterial is present
glass-ionomer-cements, ceramic
IIa Rule 19 Potential for internal
inlays, galvano inlays)
exposure of nanomaterials is
negligible
Filling materials (temporary, IIa Rule 7 or 8 Depending on usage time
provisional)
Attachments IIa Rule 8 Fixed, long-term use
Holding elements, orthodontic IIa Rule 5 Invasive product, used in the
oral cavity
Handpieces and angled pieces IIa Rule 9
(connected on motor)
Bone Rongeur, gouge pliers Ir Rule 5
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Product description Class Rule Comments
Interdental wedge I Rule 5
Handpiece with cold light I Rule 13 1r product, if reprocessing is
required
Cannulas, sterile or non-sterile I Rule 5 As addition on syringes
Cavity varnish IIa Rule 8
Cavity cleaning agents IIa Rule 6
Clamping wire IIa Rule 5, for long-term use
3 Indent (see also braces)
Bonder IIa Rule 8 Because the tooth is
conditioned by insertion, the
requirement “in the teeth” is
fulfilled
(see also adhesives and
cements)
Clamp, artery Ir Rule 6
Haemostatic Forceps
Rubber Dam, Rubber Dam Frame I Rule 5
Support structure for rubber dam
Conditioner IIa Rule 6 Transient use
Bone replacement materials IIa Rule 8 Not resorbable
III Rule 8 Resorbable
Crowns, dental crowns IIa Rule 8
Crown and bridge materials IIa Rule 7 or 8 Depending on usage time
(temporary, provisional)
Rule 19 If nanomaterial is present
Artificial teeth IIa Rule 8
Varnishers (protective I Rule 5, Short-term or transient use
varnishers, fluoriding varnishers)
st nd
1 or 2 Indent
Alloys (for crowns, bridges,
...