Recognized standard
Standard No. 131-2015 (R2020)
FDA recognition 4-255 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-255 |
|---|---|
| Designation | Standard No. 131-2015 (R2020) |
| Title | Dental CAD/CAM Machinable Zirconia Blanks |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies the requirements and test methods for partially stabilized zirconia materials used for the fabrication of dental fixed restorations. |
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: