Recognized standard
4823 Sixth edition 2025-06
FDA recognition 4-368 · ISO · Dental/ENT
Key facts
| Recognition number | 4-368 |
|---|---|
| Designation | 4823 Sixth edition 2025-06 |
| Title | Dentistry - Elastomeric impression and bite registration materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. |
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: