National foreword

This British Standard is the UK implementation of EN ISO 6876:2025. It is identical to ISO 6876:2025. It supersedes BS EN ISO 6876:2012, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials.

A list of organizations represented on this committee can be obtained on request to its committee manager.

BSI, as a member of CEN, is obliged to publish EN ISO 6876:2025 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted against its approval.

The UK committee submitted a negative vote for two reasons: firstly, due to its opinion that the testing of sealing materials that require water to set and be tested for hours (see Subclause 7.5.1) is unrealistic; secondly, because proposed testing of the efficacy of the Gillmore apparatus (see Subclause 7.5.2.2) was not completed prior to publication of this standard.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2025.

This European Standard was approved by CEN on 28 September 2025.

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, Czechia, 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.

European foreword

This document (EN ISO 6876:2025) 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 May 2026, and conflicting national standards shall be withdrawn at the latest by May 2026.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 6876:2012.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

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, 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 the United Kingdom.

Endorsement notice

The text of ISO 6876:2025 has been approved by CEN as EN ISO 6876:2025 without any modification.

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 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.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

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.

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

3 Terms and definitions

4 Classification

5 Requirements

5.1 General

5.2 Appearance

5.3 Flow (Type 1 only)

5.4 Working time (Type 1 only)

5.5 Setting time

5.6 Film thickness (Type 1 only)

5.7 Solubility and disintegration

5.8 Radiopacity

6 Sampling

7 Test methods

7.1 Test conditions

7.2 Appearance

7.3 Flow (Type 1 materials)

7.4 Working time

7.5 Setting time

7.6 Film thickness (Type 1 only)

7.7 Solubility and disintegration

7.8 Radiopacity

8 Marking, packaging and labelling

8.1 Marking

8.2 Packaging

8.3 Labelling

Bibliography

BS EN ISO 6876:2025

Dentistry — Endodontic sealing materials

Current

Published:

30 Nov 2025