Recognized standard
9693 Third edition 2019-10 Standard No. 38-2020
FDA recognition 4-263 · ISO · Dental/ENT
Key facts
| Recognition number | 4-263 |
|---|---|
| Designation | 9693 Third edition 2019-10 Standard No. 38-2020 |
| Title | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed… |
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: