Recognized standard
Standard No. 96-2020
FDA recognition 4-325 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-325 |
|---|---|
| Designation | Standard No. 96-2020 |
| Title | Dental Water-based Cements |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | Part 1 of ADA Standard No. 96 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. Part 1 is applicable to both hand-mixed and capsulated cements for mechanical mixing. Part 1 specifies limits for each of the… |
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: