Recognized standard
Standard No. 57-2021
FDA recognition 4-328 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-328 |
|---|---|
| Designation | Standard No. 57-2021 |
| Title | Endodontic Sealing Materials |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements and test methods for endodontic sealing materials, which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It covers materials intended for orthograde use… |
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: