Recognized standard
5139 First edition 2023-05
FDA recognition 4-323 · ISO · Dental/ENT
Key facts
| Recognition number | 4-323 |
|---|---|
| Designation | 5139 First edition 2023-05 |
| Title | Dentistry - Polymer-based composite machinable blanks |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and… |
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: