Recognized standard
21606 Second edition 2022-08
FDA recognition 4-304 · ISO · Dental/ENT
Key facts
| Recognition number | 4-304 |
|---|---|
| Designation | 21606 Second edition 2022-08 |
| Title | Dentistry - Elastomeric auxiliaries for use in orthodontics |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This document specifies the requirements and their test methods applicable to all elastomeric auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances. |
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: