Recognized standard
18675 First edition 2022-05
FDA recognition 4-322 · ISO · Dental/ENT
Key facts
| Recognition number | 4-322 |
|---|---|
| Designation | 18675 First edition 2022-05 |
| Title | Dentistry - Machinable ceramic blanks |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies test methods for machinable ceramic blanks used for the fabrication of dental fixed restorations. This document also specifies the contents of the test report. |
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: