Recognized standard
4823 Fifth edition 2021-02 Standard No. 19-2022
FDA recognition 4-278 · ISO · Dental/ENT
Key facts
| Recognition number | 4-278 |
|---|---|
| Designation | 4823 Fifth edition 2021-02 Standard No. 19-2022 |
| Title | Dentistry - Elastomeric impression and bite registration materials Elastomeric Impression and Bite Registration |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series. |
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: