Standards Development

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, 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 pharmacopoeias 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.