Recognized standard
3630-4 Second edition 2023-08
FDA recognition 4-333 · ISO · Dental/ENT
Key facts
| Recognition number | 4-333 |
|---|---|
| Designation | 3630-4 Second edition 2023-08 |
| Title | Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product… |
At a glance
- 1–9 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: