Recognized standard
3107 Fourth edition 2011-03-01 Standard No. 30-2013 (R2018)
FDA recognition 4-198 · ISO · Dental/ENT
Key facts
| Recognition number | 4-198 |
|---|---|
| Designation | 3107 Fourth edition 2011-03-01 Standard No. 30-2013 (R2018) |
| Title | Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements Dental Zinc Oxide-Eugenol and Zinc Oxide |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 1 |
| Scope (excerpt) | This International Standard specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. This International Standard also specifies requirements for non-eugenol cements containing… |
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: