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• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 22-Apr-2025
• 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
• Replaced By: CEN/TR 12401:2025 - Dentistry - Guidance on the classification of dental devices and accessories
• Effective Date: 07-Jul-2021

Standards Content (Sample)

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

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.

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

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.
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 Council Directive 93/42 EEC of
14 June 1993 concerning medical devices. The Directive 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 Directive.
The classification should be acceptable to Notified Bodies (NB) and Competent Authorities (CA). The Directive
describes procedures for resolving any disputes over classification between manufacturers, Notified Bodies and
Competent Authorities.
The European Commission has developed a document ”Guidelines for the Classification of Medical Devices”. This
CEN Technical Report is intended to complement that guidance. In addition, NB-MED, European Co-ordination of
Notified Bodies, have developed a series of consensus statements which also have been taken into consideration.
It will, therefore, be of value to manufacturers in making decisions with regard to the likely classification of particular
devices.
1 Scope
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.
2 Classification of dental devices and accessories
The list of dental devices and accessories given in Tables 1 to 5 should not necessarily be considered 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 2.5 of the Directive has been used for the proposed classification, i.e. ”the strictest
rules.shall apply”.
It is recommended that this list be considered in conjunction with the Directive 93/42 EEC [1] and the ”Guidelines to
the classifica
...