Foreword

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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).

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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

ISO 6876:2025

Dentistry. Endodontic sealing materials

Current

Published:

5 Nov 2025