Recognized standard
Standard No. 139-2020
FDA recognition 4-294 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-294 |
|---|---|
| Designation | Standard No. 139-2020 |
| Title | Dental Base Polymers |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | The standard is presented in two parts: 1) Denture-base polymers and 2) Orthodontic-base polymers. Part 1 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further… |
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: