Recognized standard
22112 Second edition 2017-08 Standard No. 15-2021
FDA recognition 4-310 · ISO · Dental/ENT
Key facts
| Recognition number | 4-310 |
|---|---|
| Designation | 22112 Second edition 2017-08 Standard No. 15-2021 |
| Title | Dentistry - Artificial teeth for dental prostheses Artificial Teeth for Dental Prostheses |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses. |
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: