Recognized standard
22803 First edition 2004-09-01
FDA recognition 4-145 · ISO · Dental/ENT
Key facts
| Recognition number | 4-145 |
|---|---|
| Designation | 22803 First edition 2004-09-01 |
| Title | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used - for guided tissue… |
At a glance
- 1–9 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: