Recognized standard
3630-3 Third edition 2021-06 Corrected version 2023-05 Standard No. 71-2022
FDA recognition 4-362 · ISO · Dental/ENT
Key facts
| Recognition number | 4-362 |
|---|---|
| Designation | 3630-3 Third edition 2021-06 Corrected version 2023-05 Standard No. 71-2022 |
| Title | Dentistry - Endodontic instruments - Part 3: Compactors Dentistry - Endodontic Instruments: Compactors |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies the requirements and test methods for endodontic compactors (pluggers and spreaders) which are used for the compaction of endodontic filling materials, and also heat-carriers (which are not specified in the other parts of the ISO 3630 series). This document specifies the… |
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: