Recognized standard
23298 First edition 2023-05
FDA recognition 4-397 · ISO · Dental/ENT
Key facts
| Recognition number | 4-397 |
|---|---|
| Designation | 23298 First edition 2023-05 |
| Title | Dentistry - Test methods for machining accuracy of computer-aided milling machines |
| 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 test methods to evaluate the machining accuracy of computer-aided milling machines as a part of dental CAD/CAM systems, which fabricate dental restorations, such as inlays, crowns and bridges. |
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: