ISO 6876
(Main)Dentistry — Endodontic sealing materials
Dentistry — Endodontic sealing materials
ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.
Médecine bucco-dentaire — Matériaux de scellement endodontique
L'ISO 6876:2012 spécifie les exigences et les méthodes d'essai relatives aux matériaux de scellement (endodontiques) des canaux radiculaires, dont la prise se fait avec ou sans eau et qui sont utilisés pour l'obturation définitive des canaux radiculaires avec ou sans l'aide de cônes. Elle traite uniquement des matériaux de scellement conçus pour une utilisation orthograde, c'est-à-dire l'obturation radiculaire d'une dent mise en place par voie coronaire.
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Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS 6876
ISO/TC 106/SC 1
Dentistry — Endodontic sealing
Secretariat: AFNOR
materials
Voting begins on:
Médecine bucco-dentaire — Matériaux de scellement 2025-07-02
endodontique
Voting terminates on:
2025-08-27
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 6876:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 6876:2025(en)
International
Standard
ISO/FDIS 6876
ISO/TC 106/SC 1
Dentistry — Endodontic sealing
Secretariat: AFNOR
materials
Voting begins on:
Médecine bucco-dentaire — Matériaux de scellement
endodontique
Voting terminates on:
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 SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 6876:2025(en) © ISO 2025
ii
ISO/FDIS 6876:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General .2
5.2 Appearance .3
5.3 Flow (Type 1 only) .3
5.4 Working time (Type 1 only) .3
5.5 Setting time .3
5.6 Film thickness (Type 1 only) . .3
5.7 Solubility and disintegration .3
5.8 Radiopacity .3
6 Sampling . 4
7 Test methods . 4
7.1 Test conditions .4
7.2 Appearance .4
7.2.1 General .4
7.2.2 Treatment of results .4
7.3 Flow (Type 1 materials) .4
7.3.1 General .4
7.3.2 Apparatus .4
7.3.3 Procedure .5
7.3.4 Treatment of results .6
7.4 Working time .6
7.4.1 General .6
7.4.2 Apparatus .6
7.4.3 Procedure .6
7.4.4 Treatment of results .7
7.5 Setting time .7
7.5.1 General .7
7.5.2 Apparatus .7
7.5.3 Preconditioning of the apparatus .8
7.5.4 Sample preparation .8
7.5.5 Procedure .8
7.6 Film thickness (Type 1 only) . .9
7.6.1 Apparatus .9
7.6.2 Procedure .9
7.6.3 Treatment of the results .10
7.7 Solubility and disintegration .10
7.7.1 General .10
7.7.2 Apparatus .10
7.7.3 Sample preparation .10
7.7.4 Procedure .11
7.7.5 Repetition test of solubility and dissolution . 12
7.7.6 Treatment of results . 13
7.8 Radiopacity . 13
7.8.1 General . 13
7.8.2 Apparatus . 13
7.8.3 Preparation of test specimens .14
iii
ISO/FDIS 6876:2025(en)
7.8.4 Procedure .14
7.8.5 Treatment of results .14
8 Marking, packaging and labelling .15
8.1 Marking . 15
8.2 Packaging . 15
8.3 Labelling . 15
Annex A (informative) Working time determination test for Type 1 materials . 17
Bibliography .
...
Style Definition
ISO/FDIS 6876 .
ISO/TC 106/SC 1
Secretariat: AFNOR
Date: 2025-06-18
Dentistry — Endodontic sealing materials
Médecine bucco-dentaire — Matériaux de scellement endodontique
FDIS stage
ISO/DIS FDIS 6876:2024(E2025(en)
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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ii
ISO/DISFDIS 6876:20242025(en)
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Contents
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Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 General . 3
5.2 Appearance . 3
5.3 Flow (Type 1 only) . 3
5.4 Working time (Type 1 only) . 3
5.5 Setting time . 3
5.6 Film thickness (Type 1 only) . 3
5.7 Solubility and disintegration . 4
5.8 Radiopacity . 4
6 Sampling . 4
7 Test methods . 4
7.1 Test conditions . 4
7.2 Appearance . 4
7.3 Flow (Type 1 materials) . 4
7.4 Working time . 6
7.5 Setting time . 7
7.6 Film thickness (Type 1 only) . 9
7.7 Solubility and disintegration . 10
7.8 Radiopacity . 13
8 Marking, packaging and labelling . 14
8.1 Marking . 14
8.2 Packaging . 14
8.3 Labelling . 14
Annex A (informative) Working time determination test for Type 1 materials . 17
Bibliography . 21
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ISO/DIS FDIS 6876:2024(E2025(en)
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Foreword
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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 document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
Restorative Materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO
and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 6876:2012), which has been technically revised.
The main changes to the previous edition are as follows:
— endodontic sealing materials, other than orthograde endodontic sealing material used with endodontic
obturating materials, have been included;
— two types of endodontic sealing materials have been defined and classified;
— mould material has been changed from gypsum to metal or other non-reactive materials for the setting
time test;
— test methods for flow, working time, setting times and solubility have been augmented for clarity and
convenience;
— ISO 13116 for the determination of radiopacity has been added as a normative reference;
— an alternative test method has been added for working time to Annex A.
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Any feedback or questions on this document should be directed to the user’s national standards body. A
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complete listing of these bodies can be found at www.iso.org/members.html.
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iv
ISO/DISFDIS 6876:20242025(en)
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Introduction
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Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological
risks are not included in this document but it is recommended that, for the assessment of such biological risks,
reference be made to ISO 7405 and ISO 10993-1.
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v
ISO/DISFDIS 6876:20242025(en)
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Dentistry — Endodontic sealing materials
1 Scope
This document specifies the classification, requirements and test methods for endodontic sealing materials
used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and
materials used for other endodontic sealing procedures including apexification, perforation filling, resorption
treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not
address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of
validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
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.
ISO 1942, Dentistry — Vocabulary
ISO 3630-1, Dentistry — Endodontic instruments — Part 1: General requirements
ISO 13116:2014, Dentistry — Test method for determining radio-opacity of materials
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 3630-1 and the following
apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
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ISO/DIS FDIS 6876:2024(E2025(en)
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3.1
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endodontic obturating material
radio-opaqueradiopaque dental material used in the form of a point, carrier-based obturating device, or
injection material used in combination with an endodontic sealing material (3.2) to fill voids and seal root
canals during orthograde obturation
Note 1 to entry: Endodontic obturating points are used with endodontic sealers.
1)
[SOURCE: ISO 6877:20— , 3.12, modified from: substance intended as a definitive product— Note 1 to fill a
prepared root canal system, usually a combination of points and endodontic sealer]entry has been added.]
3.2
endodontic sealing material
materials intended to permanently seal the root canal system usually used in combination with endodontic
obturating points during orthograde obturation, i.e. filling a root canal from the coronal part of a tooth, or
materials used for other endodontic sealing procedures including apexification, perforation filling, resorption
treatment
...
PROJET FINAL
Norme
internationale
ISO/FDIS 6876
ISO/TC 106/SC 1
Médecine bucco-dentaire —
Secrétariat: AFNOR
Matériaux de scellement
Début de vote:
endodontique
2025-07-02
Dentistry — Endodontic sealing materials
Vote clos le:
2025-08-27
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO/FDIS 6876:2025(fr) © ISO 2025
PROJET FINAL
ISO/FDIS 6876:2025(fr)
Norme
internationale
ISO/FDIS 6876
ISO/TC 106/SC 1
Médecine bucco-dentaire —
Secrétariat: AFNOR
Matériaux de scellement
Début de vote:
endodontique
2025-07-02
Dentistry — Endodontic sealing materials
Vote clos le:
2025-08-27
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2025 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO/FDIS 6876:2025(fr) © ISO 2025
ii
ISO/FDIS 6876:2025(fr)
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Classification . 2
5 Exigences . 3
5.1 Généralités .3
5.2 Aspect .3
5.3 Fluage (type 1 uniquement) .3
5.4 Temps de travail (type 1 uniquement) .3
5.5 Temps de prise .3
5.6 Épaisseur de la pellicule (type 1 uniquement) .3
5.7 Solubilité et désagrégation .3
5.8 Radio-opacité .4
6 Échantillonnage . 4
7 Méthodes d’essai . 4
7.1 Conditions d’essai . . .4
7.2 Aspect .4
7.2.1 Généralités .4
7.2.2 Traitement des résultats .4
7.3 Fluage (matériaux de type 1) .4
7.3.1 Généralités .4
7.3.2 Appareillage.5
7.3.3 Mode opératoire . .5
7.3.4 Traitement des résultats .6
7.4 Temps de travail .6
7.4.1 Généralités .6
7.4.2 Appareillage.6
7.4.3 Mode opératoire . .7
7.4.4 Traitement des résultats .7
7.5 Temps de prise .7
7.5.1 Généralités .7
7.5.2 Appareillage.7
7.5.3 Préconditionnement de l’appareillage .8
7.5.4 Préparation de l’échantillon .8
7.5.5 Mode opératoire . .8
7.6 Épaisseur de la pellicule (type 1 uniquement) .9
7.6.1 Appareillage.9
7.6.2 Mode opératoire . .9
7.6.3 Interprétation des résultats .10
7.7 Solubilité et désagrégation .10
7.7.1 Généralités .10
7.7.2 Appareillage.10
7.7.3 Préparation de l’échantillon .11
7.7.4 Mode opératoire . .11
7.7.5 Essai de répétition de solubilité et de dissolution . 12
7.7.6 Traitement des résultats . 13
7.8 Radio-opacité . 13
7.8.1 Généralités . 13
7.8.2 Appareillage. 13
7.8.3 Préparation des éprouvettes .14
iii
ISO/FDIS 6876:2025(fr)
7.8.4 Mode opératoire . .14
7.8.5 Traitement des résultats .14
8 Marquage, emballage et étiquetage.15
8.1 Marquage . 15
8.2 Emballage . 15
8.3 Étiquetage . 15
Annexe A (informative) Essai de détermination du temps de travail pour les matériaux de
type 1 .
...
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