Recognized standard
Standard No. 135-2015 (R2020)
FDA recognition 4-371 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-371 |
|---|---|
| Designation | Standard No. 135-2015 (R2020) |
| Title | Denture Adhesives |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 25, 2026 |
| Device classes | Class 1, Class 3 |
| Scope (excerpt) | This standard classifies metallic materials that are suitable for the fabrication of dental appliances and restorations, including metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses, and specifies their requirements. |
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: