Recognized standard
10477 Fourth edition 2020-10 Standard No. 53-2022
FDA recognition 4-302 · ISO · Dental/ENT
Key facts
| Recognition number | 4-302 |
|---|---|
| Designation | 10477 Fourth edition 2020-10 Standard No. 53-2022 |
| Title | Dentistry - Polymer-based crown and veneering materials Polymer-Based Crown and Veneering Materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for polymer-based crown and veneering materials used in dentistry. This document applies to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and… |
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: