Recognized standard
3630-1 Third edition 2019-08 Standard No. 101-2021
FDA recognition 4-360 · ISO · Dental/ENT
Key facts
| Recognition number | 4-360 |
|---|---|
| Designation | 3630-1 Third edition 2019-08 Standard No. 101-2021 |
| Title | Dentistry - Endodontic instruments - Part 1: General requirements Endodontic Instruments - General Requirements |
| 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 general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding… |
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: