Recognized standard
3630-5 Second edition 2020-08 Standard No. 28-2021
FDA recognition 4-363 · ISO · Dental/ENT
Key facts
| Recognition number | 4-363 |
|---|---|
| Designation | 3630-5 Second edition 2020-08 Standard No. 28-2021 |
| Title | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments Endodontic Instruments - Shaping and Cleaning Instruments |
| 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 requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety… |
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: