CEN/TR 12401:2023

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

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.

FprCEN/TR 12401:2022 (E)
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

FprCEN/TR 12401:2022 (E)
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.
FprCEN/TR 12401:2022 (E)
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.
FprCEN/TR 12401:2022 (E)
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
FprCEN/TR 12401:2022 (E)
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
FprCEN/TR 12401:2022 (E)
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
FprCEN/TR 12401:2022 (E)
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
FprCEN/TR 12401:2022 (E)
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
rd
3 Indent
Brackets IIa Rule 5 Long-term use
Calcium hydroxide, IIa Rule 8
Calcium salicylate,
Calcium sulfate
rd
Expansion screws IIa Rule 5, 3 Indent Long-term use
Dental implants and abutments IIb Rule
...