Recognized standard
6877 Third edition 2021-09 Standard No. 78-2022
FDA recognition 4-309 · ISO · Dental/ENT
Key facts
| Recognition number | 4-309 |
|---|---|
| Designation | 6877 Third edition 2021-09 Standard No. 78-2022 |
| Title | Dentistry - Endodontic obturating materials Dentistry - Endodontic Obturating Materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: