Recognized standard
22112 First edition 2005-11-01 Standard No. 15-2008 (R2013)
FDA recognition 4-151 · ISO · Dental/ENT
Key facts
| Recognition number | 4-151 |
|---|---|
| Designation | 22112 First edition 2005-11-01 Standard No. 15-2008 (R2013) |
| 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 | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry. |
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: