kSIST-TP FprCEN/TR 12401:2023

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
• Public Enquiry End Date: 17-Jan-2023
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 5520 - Unique Acceptance Procedure (UAP) (Adopted Project)
• Start Date: 03-Nov-2022
• Due Date: 23-Mar-2023
• Completion Date: 16-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: CEN/TR 12401:2023 - Dentistry - Guidance on the classification of dental devices and accessories

Relations

• Revised: SIST-TP CEN/TR 12401:2009 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 19-Jan-2023
• Revised: SIST-TP CEN/TR 12401:2009 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 18-Jan-2023
• Revised: SIST-TP 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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kSIST-TP FprCEN/TR 12401:2023
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 .
...