Recognized standard
Standard No. 141-2013 (R2023)
FDA recognition 4-372 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-372 |
|---|---|
| Designation | Standard No. 141-2013 (R2023) |
| Title | Dentistry-Dental Duplicating Material |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible molds needed to produce positive refractory investment copies of properly blocked-out master models. |
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: