SIST EN ISO 16443:2014

Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)

EN ISO 16443 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from this International Standard. The following devices are also excluded from the scope of this International Standard. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions): - epithesis implant; - craniofacial implant; - maxillofacial implant. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance: - orthodontic implant.

Zahnheilkunde- Vokabular der oralen Implantologie (ISO 16443:2014)

Dieses Dokument legt Begriffe für Dentalimplantate und für Instrumente, Zubehör sowie die am häufigsten verwendeten klinischen Begriffe im Zusammenhang mit Implantatsystemen und Verfahren in der Zahnheilkunde fest. Augmentationsmaterialien und Membrane sind von dieser Norm ausgenommen.
Die folgenden Produkte sind ebenfalls vom Anwendungsbereich dieses Dokuments ausgenommen.
Produkte, die speziell zum Einsetzen in die Knochen, durch die Knochen oder auf den Knochen des kraniofazialen Komplexes vorgesehen sind; und deren Hauptzweck darin besteht, eine Verankerung für eine Epithese (als Ersatz zum Beispiel für Ohren, Nase, Teile der Augen und des Orbitalbereiches) anzubieten:
   Epithesenimplantat;
   kraniofaziales Implantat;
   maxillofaziales Implantat.
Produkte, die speziell zum Einsetzen in die Knochen, durch die Knochen oder auf den Knochen des kraniofazialen Komplexes vorgesehen sind; und deren Hauptzweck darin besteht, eine Verankerung für eine kieferorthopädische Apparatur anzubieten:
   kieferorthopädisches Implantat. )

Médecine bucco-dentaire - Vocabulaire des systèmes d'implants dentaires et procédure associée (ISO 16443:2014)

L'ISO 16443:2014 spécifie les termes et définitions relatifs aux implants dentaires, aux instruments et aux accessoires, ainsi que les termes cliniques les plus couramment employés en médecine bucco-dentaire dans le domaine des procédures et des systèmes implantaires. Les matériaux de greffe osseuse et les membranes ne sont pas traités dans l'ISO 16443:2014.
Les dispositifs suivants ne relèvent pas non plus du domaine d'application de l'ISO 16443:2014.
Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à une épithèse (pour remplacer par exemple les oreilles, le nez et certaines parties des yeux et des régions orbitales):
       implant pour épithèse;
       implant cranio-facial;
       implant maxillo-facial.
Les dispositifs spécialement conçus pour être placés à l'intérieur, au travers ou à la surface des os du complexe cranio-facial, dont le but principal est de servir d'ancrage à un appareil orthodontique:
       implant orthodontique.

Zobozdravstvo - Slovar za sisteme dentalnih vsadkov (implantatov) in z njimi povezane postopke (ISO 16443:2014)

Standard EN ISO 16443 določa izraze in definicije za dentalne vsadke ter instrumente, pripomočke in najbolj pogosto uporabljene klinične izraze, povezane s sistemi dentalnih vsadkov in postopkov v zobozdravstvu. Materiali za presaditev in membrane niso vključene v tem mednarodnem standardu. Naslednji pripomočki prav tako ne spadajo na področje uporabe tega mednarodnega standarda. Pripomoček, ki je posebej zasnovan tako, da se namesti v lobanjsko-obrazne kosti, skozi nje ali nanje, katerega osnovni namen je zagotoviti sidrišče za epitezo (za nadomestitev na primer ušesa, nosu in delov oči ter orbitalne regije): – vsadek epiteza; – lobanjsko-obrazni vsadek; – maksilofacialni vsadek. Pripomoček, ki je posebej zasnovan tako, da se namesti v lobanjsko-obrazne kosti, skozi nje ali nanje, katerega osnovni namen je zagotoviti sidrišče za ortodontski pripomoček. – ortodontski vsadek.

General Information

• Status: Published
• Public Enquiry End Date: 29-Oct-2013
• Publication Date: 04-Sep-2014
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.060.15 - Dental implants
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Aug-2014
• Due Date: 11-Oct-2014
• Completion Date: 05-Sep-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN ISO 16443:2014 - Dentistry - Vocabulary for dental implants systems and related procedure (ISO 16443:2014)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16443:2014
01-oktober-2014
Zobozdravstvo - Slovar za sisteme dentalnih vsadkov (implantatov) in z njimi
povezane postopke (ISO 16443:2014)
Dentistry - Vocabulary for dental implants systems and related procedure (ISO
16443:2014)
Zahnheilkunde- Vokabular der oralen Implantologie (ISO 16443:2014)
Médecine bucco-dentaire - Vocabulaire des systèmes d'implants dentaires et procédure
associée (ISO 16443:2014)
Ta slovenski standard je istoveten z: EN ISO 16443:2014
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.060.15 Zobni implantati Dental implants
SIST EN ISO 16443:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16443:2014

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SIST EN ISO 16443:2014

EUROPEAN STANDARD
EN ISO 16443

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2014
ICS 01.020; 11.060.01
English Version
Dentistry - Vocabulary for dental implants systems and related
procedure (ISO 16443:2014)
Médecine bucco-dentaire - Vocabulaire des systèmes Zahnheilkunde- Vokabular der oralen Implantologie (ISO
d'implants dentaires et procédure associée (ISO 16443:2014)
16443:2014)
This European Standard was approved by CEN on 28 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16443:2014 E
worldwide for CEN national Members.

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SIST EN ISO 16443:2014
EN ISO 16443:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 16443:2014
EN ISO 16443:2014 (E)
Foreword
This document (EN ISO 16443:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in
collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16443:2014 has been approved by CEN as EN ISO 16443:2014 without any modification.
3

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SIST EN ISO 16443:2014

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SIST EN ISO 16443:2014
INTERNATIONAL ISO
STANDARD 16443
NORME
First edition
Première édition
INTERNATIONALE 2014-07-15
Dentistry — Vocabulary for dental
implants systems and related
procedure
Médecine bucco-dentaire — Vocabulaire des systèmes d’implants
dentaires et procédures associées
Reference number
Numéro de référence
ISO 16443:2014(E/F)
©
ISO 2014

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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)

COPYRIGHT PROTECTED DOCUMENT
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland/Publié en Suisse
iiii  © ISO 2014 – All rig© ISO 2014 – All rights rhts reserveserved/Ted/Tous drous droits roits réservéservésés

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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions related on medical devices used in oral implantology .1
3.1 Dental implant . 1
3.2 Dental implant system . 2
3.3 Ancillary devices used in oral implantology. 6
4 Terms and definitions related to clinical and surgical concepts used in oral implantology .8
Bibliography .12
© ISO 2014 – All rights reserved/Tous droits réservés iii

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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 3, Terminology.
ISO is now publishing all its standards using a processing system that allows the production of
International Standards as XML files. With this new system, the terms and definitions from terminologies
and vocabularies are stored in the Online Browsing Platform (OBP) (www.iso.org/obp) where they can
be browsed free of charge by members of the public (but not downloaded).
iv © ISO 2014 – All rights reserved/Tous droits réservés

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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)

Introduction
This terminology international standard has been prepared and is presented accordingly with
recommendations provided in
ISO 704, Terminology work — Principles and methods,
ISO 860, Terminology work — Harmonization of concepts and terms,
ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application, and
ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation.
Accordingly to ISO directives, ISO 704 and ISO 1087, this standard has been prepared and is presented
in a systematic approach. The systematic approach presents the advantage of being independent from
language, therefore allowing the same logical numbering in any language.
© ISO 2014 – All rights reserved/Tous droits réservés v

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SIST EN ISO 16443:2014

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SIST EN ISO 16443:2014
INTERNATIONAL STANDARD ISO 16443:2014(E/F)
Dentistry — Vocabulary for dental implants systems and
related procedure
1 Scope
This International Standard specifies terms and definitions for dental implants and for instruments,
accessories, and the most commonly used clinical terms related to implant systems and procedures in
dentistry. Grafting materials and membranes are excluded from this International Standard.
The following devices are also excluded from the scope of this International Standard.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears,
noses and parts of eyes and orbital regions):
— epithesis implant;
— craniofacial implant;
— maxillofacial implant.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purpose of which is to provide anchorage for an orthodontic appliance:
1)
— orthodontic implant .
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
NOTE Except for the following terminological entries that supersede ISO 1942:2009, the terms and definitions
given in ISO 1942 apply for the purpose of this document.
3 Terms and definitions related on medical devices used in oral implantology
For the purposes of this document, the following terms and definitions apply.
3.1 Dental implant
3.1.1
dental implant
device especially designed to be placed within, through or upon the bones of the cranio-facial complex,
the primary purposes of which are to support and/or to resist displacement of a dental prosthesis
3.1.1.1
endosseous dental implant
endosteal implant (DEPRECATED)
dental implant (3.1.1) placed partially or entirely within the bone
1) This definition supersedes the one given in ISO 1942.
© ISO 2014 – All rights reserved/Tous droits réservés 1

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SIST EN ISO 16443:2014
ISO 16443:2014(E/F)

3.1.1.2
interim endosseous dental implant
provisional implant
endosseous dental implant (3.1.1.1) for temporary usage
3.1.1.3
transendodontic implant
endodontic endosseous implant
transradicular implant (DEPRECATED)
rod, specially made to be inserted longitudinally either through a root canal or through a root segment
which extends through the apex into the surrounding bone to stabilize a tooth
3.1.1.4
intramucosal implant
oral mucosal insert
submucosal implant (DEPRECATED)
button implant (DEPRECATED)
dental implant (3.1.1) placed in the soft tissue lining of the oral cavity
3.1.1.5
ramus endosseous implant
ramus endosteal implant (DEPRECATED)
dental implant (3.1.1) placed within the ramus of the mandible
3.1.1.6
frame implant
ramus frame endosteal implant (DEPRECATED)
One-piece implant consisting of a number of mandibular subperiosteal and/or endosseous components
linked with an intra-oral structure
3.1.1.7
subperiosteal dental implant
subperiosteal implant abutment (DEPRECATED)
dental implant (3.1.1) that is placed beneath the periosteum and overlying the bony cortex
3.1.1.8
transmandibular implant
dental implant (3.1.1) consisting of a plate and posts designed so that the posts can be placed to extend
vertically from the inferior border of the mandible through the plate, bone and mucosa and into the oral
cavity in the anterior region
3.1.1.9
zygoma implant
dental implant (3.1.1) intended to be partially inserted into or on the zygomatic bone
3.2 Dental implant system
3.2.1
dental implant system
implant kit
implant system
integrated system of components, specific equipment and ancillary instruments necessary for the
clinical and laboratory procedures required for the placement of the dental implant (3.1.1) and the
construction and insertion of an implant-supported dental prosthesis
3.2.2
implant component
element of a dental implant system (3.2.1)
2 © ISO 2014 – All rights reserved/Tous droits réservés

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SIST EN ISO 16443
...

SLOVENSKI STANDARD
oSIST prEN ISO 16443:2013
01-oktober-2013
Zobozdravstvo - Terminologija oralne implantologije (ISO/DIS 16443:2013)
Dentistry - Terminology of oral implantology (ISO/DIS 16443:2013)
Zahnheilkunde - Terminologie der oralen Implantologie (ISO/DIS 16443:2013)
Médecine bucco-dentaire - Vocabulaire d'implantologie buccale (ISO/DIS 16443:2013)
Ta slovenski standard je istoveten z: prEN ISO 16443
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.060.01 Zobozdravstvo na splošno Dentistry in general
oSIST prEN ISO 16443:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 16443:2013

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oSIST prEN ISO 16443:2013

DRAFT INTERNATIONAL STANDARD ISO/DIS 16443
ISO/TC 106/SC 3 Secretariat: AFNOR
Voting begins on Voting terminates on

2013-04-25 2013-09-25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION


Dentistry — Vocabulary of oral implantology
Médecine bucco-dentaire — Vocabulaire d'implantologie buccale
ICS 01.020; 11.060.01





ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2013

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oSIST prEN ISO 16443:2013
ISO/DIS 16443

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any
means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission.
Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2013 – All rights reserved

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oSIST prEN ISO 16443:2013
ISO/DIS 16443
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Medical devices used in oral implantology . 1
3.1 Dental implant . 1
3.2 Dental implant system . 2
3.3 Ancillary devices used in oral implantology . 5
4 Clinical and surgical concepts used in oral implantology . 7
Bibliography . 11
Alphabetical index . 12





© ISO 2013 – All rights reserved iii

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oSIST prEN ISO 16443:2013
ISO/DIS 16443
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
This first edition of ISO 16443 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 3, Terminology, in collaboration with CEN/TC 55, Dentistry.



iv © ISO 2013 – All rights reserved

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oSIST prEN ISO 16443:2013
ISO/DIS 16443
Introduction
This terminology international standard has been prepared and is presented accordingly with
recommendations provided in:
ISO 704, Terminology work — Principles and methods;
ISO 860, Terminology work — Harmonization of concepts and terms;
ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application; and
ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation.
Accordingly to ISO directives, ISO 704 and ISO 1087, this standard has been prepared and is presented in a
systematic approach. The systematic approach presents the advantage of being independent from language,
therefore allowing the same logical numbering in any language.

© ISO 2013 – All rights reserved v

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oSIST prEN ISO 16443:2013

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oSIST prEN ISO 16443:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 16443
Dentistry — Vocabulary of oral implantology
1 Scope
This document specifies terms and definitions for dental implants and for instruments, accessories, and the
most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials
and membranes are excluded from this standard.
The following devices are also excluded from the scope of this document.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the
primary purpose of which is to provide anchorage for an epithesis (to replace for example : ears, noses and
parts of eyes and orbital regions):
epithesis implant;
craniofacial implant;
maxillofacial implant.
Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the
primary purpose of which is to provide anchorage for an orthodontic appliance:
1)
orthodontic implant
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary.
For the purposes of this document, the terms and definitions given in ISO 1942 apply.
3 Medical devices used in oral implantology
3.1 Dental implant
3.1
dental implant
device especially designed to be placed within, through or upon the bones of the cranio-facial complex, the
primary purposes of which are to support and/or to resist displacement of a dental prosthesis
3.1.1
endosseous dental implant
endosteal implant (deprecated)
dental implant (3.1) placed partially or entirely within the bone
1) This definition supersedes the one given in ISO 1942.
© ISO 2013 – All rights reserved
1

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oSIST prEN ISO 16443:2013
ISO/DIS 16443
3.1.2
interim endosseous dental implant
provisional implant
endosseous dental implant (3.1.1) for temporary usage
3.1.3
transendodontic implant
endodontic endosseous implant
transradicular implant (deprecated)
rod, specially made to be inserted longitudinally either through a root canal or through a root segment which
extends through the apex into the surrounding bone to stabilize a tooth
3.1.4
intramucosal implant
oral mucosal insert
submucosal implant
button implant (deprecated)
dental implant (3.1) placed in the soft tissue lining of the oral cavity
3.1.5
ramus endosseous implant
ramus endosteal implant (deprecated)
dental implant (3.1) placed within the ramus of the mandible
3.1.6
frame implant
ramus frame endosteal implant (deprecated)
endosseous implant and/or subperiosteal implant, placed in or on the mandibular bone and connected to an
implant superstructure (4.23.1)
3.1.7
subperiosteal dental implant
subperiosteal implant abutment (deprecated)
dental implant (3.1) that is placed beneath the periosteum and overlying the bony cortex
3.1.8
transmandibular implant
dental implant (3.1) consisting of a plate and posts designed so that the posts can be placed to extend
vertically from the inferior border of the mandible through the plate, bone and mucosa and into the oral cavity
usually in the anterior region
3.2 Dental implant system
3.2
dental implant system
implant kit
implant system
integrated system of components, specific equipment and ancillary instruments necessary for the clinical and
laboratory procedures required for the placement of the dental implant (3.1) and the construction and
insertion of an implant-supported dental prosthesis
3.2.1
implant component
element of a dental implant system (3.2)
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oSIST prEN ISO 16443:2013
ISO/DIS 16443
3.2.2
implant body
dental implant body
implant fixture (deprecated)
endosteal implant body (deprecated)
primary single component or portion of a dental implant (3.1) which is intended to remain within the tissues.
The implant body (3.2.2) can be totally submerged by soft tissue, or partially penetrating soft tissue.
3.2.3
transmucosal component
part of a dental implant system (3.2) that passes through the mucosa
3.2.4
tissue interface surface
implant biological contact surface
surface of an implant body (3.2.2) or implant component (3.2.1) intended to contact host’s tissues
3.2.5
implant component biological surface treatment
modification of a dental implant component (3.2.1) surface by subtraction or addition of material, including
the constitutive material
3.2.5.1
implant component coating
layer of material, different from the constitutive material of the implant component, used to cover or partially
cover a defined surface of an implant body (3.2.2) or an implant component (3.2.1)
3.2.6
connecting interface
implant connective platform
attachement end
portion of a dental implant body (3.2.2) or implant component (3.2.1) intended to connect with another
implant component (3.2.1)
3.2.6.1
platform switching
connecting interface (3.2.6) designed to allow the use of the same implant component (3.2.1)
independently from the diameter of the implant body (3.2.2)
3.2.7
anti-rotation feature
shape of the implant connective platform (3.2.6), that prevents rotation of the connected implant
component (3.2.1) around the long axis of the implant body (3.2.2)
3.2.7.1
external anti-rotation feature
anti-rotation feature (3.2.7) extending outside the implant body (3.2.2)
3.2.7.2
internal anti-rotation feature
anti-rotation feature (3.2.7) shaped within the implant body (3.2.2)
3.2.8
implant abutment
implant component (3.2.1) connected to the implant body (3.2.2) or implant connecting part (3.2.9),
which serves as an abutment
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oSIST prEN ISO 16443:2013
ISO/DIS 16443
3.2.8.1
angulated implant abutment
implant abutment (3.2.8) having a long axis divergent from that of the implant body (3.2.2)
3.2.9
implant connecting part
dental implant connecting part
implant component (3.2.1) used between the implant body (3.2.2) and the implant abutment (3.2.8)
3.2.10
monopart implant
monotype implant
endosseous dental implant (3.1.1) made in one piece that consists of the implant body (3.2.2) part and an
implant abutment (3.2.8)
3.2.11
two-part implant
endosseous dental implant (3.1.1) consisting of an implant body (3.2.2) to which is connected an implant
abutment (3.2.8) or a prosthesis
3.2.12
multi part implant
two parts implant (3.2.11) with the addition of one or more implant connecting parts (3.2.9)
3.2.13
implant cover screw
cover screw
implant component (3.2.1) used in phase one or placement surgery to close the screw access hole and
prevent tissue growth on and into the attachment end (3.2.6) of an implant body (3.2.2)
3.2.14
transmucosal healing component
implant healing abutment
implant component (3.2.1) that projects into the oral cavity and is used for a limited time to guide healing of
the surrounding soft tissues
3.2.15
abutment screw
centre screw (deprecated)
implant component (3.2.1) used to attach an implant abutment (3.2.8) to an implant body (3.2.2)
3.2.16
prosthetic screw
horizontal screw
occlusal screw
implant component (3.2.1) screw which fixes the implant superstructure (4.23.1) to the implant body
(3.2.2), implant connecting part (3.2.9) or implant abutment (3.2.8)
3.2.17
implant connecting part screw
implant component (3.2.1) which fixes an implant connecting part (3.2.9) to an implant body (3.2.2)
3.2.18
implant analogue GB
implant analog US
implant laboratory replica
implant component (3.2.1) intended for inclusion in a working model or cast to replicate the connecting
interface of an implant body (3.2.2) or implant component (3.2.1) for laboratory procedures
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oSIST prEN ISO 16443:2013
ISO/DIS 16443
3.2.19
implant impression coping
implant impression cap
implant transfer post
implant impression post
implant component (3.2.1) used to transfer the position of the connecting interface (3.2.6) to the working
cast/model by means of an impression
3.2.20
abutment analog
implant component (3.2.1) directly connected to the implant laboratory replica (3.2.18) and used only for
the preparation of the implant superstructure (4.23.1) in the dental laboratory and not intended for clinical
use
3.3 Ancillary devices used in oral implantology
3.3.1
implant screwdriver
tool for tightening and/or removing (loosening) screws that connect implant components (3.2.1) and
prosthesis
3.3.2
bone thread cutter
bone tap
bone thread former
rotary instrument for preparation of a screw thread in the prepared implant osteotomy site
3.3.3
profile drill
stepped drill
calibrated rotary instrument for preparation of the implant osteotomy site in various shapes and lengths, so as
to precisely fit the implant body (3.2.2)
3.3.4
implant insertion preassembled device
insertion transfer device
fixture mount (deprecated)
device to which an implant body (3.2.2) may be temporarily secured to facilitate its placement in the prepared
osteotomy site
3.3.5
holding bar
holding key
device designed to hold the implant body (3.2.2) in the planned position during placement with a wrench
3.3.6
pilot drill
spiral drill
rotary instrument used to prepare a preliminary hole for the implant osteotomy site
3.3.7
drill extension
bur extension
accessory for the elongation of drills, burs and thread cutters during preparation of the implant socket
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oSIST prEN ISO 16443:2013
ISO/DIS 16443
3.3.8
abutment finisher
crown base finisher
finishing instrument for planned removal of oxide layers on the implant abutment (3.2.8)
3.3.9
rotary tissue punch
soft tissue trepan
tissue punch
central knife
instrument for removal of soft tissue over the implant body (3.2.2)
3.3.10
ratchet wrench
force transferring instrument, used for preparation of the implant osteotomy site or the insertion of the implant
body (3.2.2) or as a holder for the implant screwdriver (3.3.1)
3.3.11
torque wrench
ratchet wrench (3.3.10) with a measurable torque and/or torque limitation
3.3.12
ratchet wrench insert
applicator
torque wrench adapter
ratchet adapter
device inserted into the wrench or the torque wrench (3.3.11) to connect with the rotated tool or implant
body (3.2.2)
3.3.13
implant mallet
mallet for insertion of the impacted implant body (3.2.2)
3.3.14
insertion instrument
impact transferring device
mallet force transferring device
instrument for transferring the force between implant mallet (3.3.13) and impacted implant body (3.2.2)
3.3.15
paralleling device
alignment pin
graduated rod inserted in the implant socket during its preparation so as to aid in its orientation and depth
3.3.16
template
physical or virtual artefact fabricated to aid in the planning and/or treatment of a patient with a dental impla
...