Recognized standard
Standard No. 96-2012
FDA recognition 4-215 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-215 |
|---|---|
| Designation | Standard No. 96-2012 |
| Title | Dental Water-based Cements |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | Part 1 of this standard specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed and capsulated cements for mechanical mixing and specifies limits for each of the properties… |
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: