CEN/TR 12401:2009

Dentistry - Guidance on the classification of dental devices and accessories

This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.

Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehör

Dieser europäische Technische Bericht gibt eine Anleitung für die Anwendung der Klassifizierungsregeln der EG Richtlinie 93/42 EWG vom 14. Juni 1993 für Medizinprodukte bezogen auf Dentalprodukte und Zubehör.

Art dentaire - Lignes directrices pour 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 la Directive 93/42 CEE du Conseil du 14 juin 1993, amendée par la Directive
2007/47/CE, concernant les dispositifs médicaux dans la mesure où elles concernent les dispositifs médicaux
utilisés en art dentaire et leurs accessoires.

Zobozdravstvo - Napotki za razvrščanje zobozdravstvenih naprav in pripomočkov

General Information

• Status: Published
• Publication Date: 12-May-2009
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55/WG 3 - Classification
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 13-May-2009
• Due Date: 13-Dec-2009
• Completion Date: 13-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST-TP CEN/TR 12401:2009 - Dentistry - Guidance on the classification of dental devices and accessories

Relations

• Replaces: CEN/TR 12401:2003 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 22-Dec-2008
• Revised: CEN/TR 12401:2023 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 07-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 12401:2009
01-oktober-2009
1DGRPHãþD
SIST-TP CEN/TR 12401:2003
=RER]GUDYVWYR1DSRWNL]DUD]YUãþDQMH]RER]GUDYVWYHQLKQDSUDYLQSULSRPRþNRY
Dentistry - Guidance on the classification of dental devices and accessories
Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehör
Art dentaire - Lignes directrices pour la classification des dispositifs dentaires et
accessoires
Ta slovenski standard je istoveten z: CEN/TR 12401:2009
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
SIST-TP CEN/TR 12401:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 12401:2009

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SIST-TP CEN/TR 12401:2009
TECHNICAL REPORT
CEN/TR 12401
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
May 2009
ICS 11.060.01 Supersedes CEN/TR 12401:2003
English Version
Dentistry - Guidance on the classification of dental devices and
accessories
Art dentaire - Lignes directrices pour la classification des Zahnheilkunde - Anleitung zur Klassifizierung von
dispositifs dentaires et accessoires Dentalprodukten und Zubehör
This Technical Report was approved by CEN on 5 April 2009. It has been drawn up by the Technical Committee CEN/TC 55.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 12401:2009: E
worldwide for CEN national Members.

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SIST-TP CEN/TR 12401:2009
CEN/TR 12401:2009 (E)
Contents
Foreword . 3
Introduction . 4
1 Scope . 5
2 Classification of dental devices and accessories . 5
3 Proposals for classification of dental devices and accessories . 5
Bibliography . 10

Tables
Table 1 — Invasive devices used in the oral cavity . 5
Table 2 — Invasive devices used in the oral cavity by the patient . 8
Table 3 — Non invasive devices . 8
Table 4 — Instruments . 8
Table 5 — Equipment . 9

2

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SIST-TP CEN/TR 12401:2009
CEN/TR 12401:2009 (E)
Foreword
This document (CEN/TR 12401:2009) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the
secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN/TR 12401:2003.
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.
3

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SIST-TP CEN/TR 12401:2009
CEN/TR 12401:2009 (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 pharmaceutica
...