International standard
Dentistry — Endodontic obturating materials
Published Aug 1, 2025
This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use. Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration. Clause 7 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0037000000 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.
Withdrawn · Sep 8, 2021