Recognized standard
10477 Third edition 2018-06
FDA recognition 4-248 · ISO · Dental/ENT
Key facts
| Recognition number | 4-248 |
|---|---|
| Designation | 10477 Third edition 2018-06 |
| Title | Dentistry - Polymer-based crown and veneering materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for… |
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: