Recognized standard
21850-1 First edition 2020-04 Standard No. 196-2021
FDA recognition 4-395 · ISO · Dental/ENT
Key facts
| Recognition number | 4-395 |
|---|---|
| Designation | 21850-1 First edition 2020-04 Standard No. 196-2021 |
| Title | Dentistry - Materials for dental instruments - Part 1: Stainless steel Materials for Dental Instruments - Part 1: Stainless Steel |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is… |
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: