Recognized standard
3107 Fifth edition 2022-09 Standard No. 30-2023
FDA recognition 4-299 · ISO · Dental/ENT
Key facts
| Recognition number | 4-299 |
|---|---|
| Designation | 3107 Fifth edition 2022-09 Standard No. 30-2023 |
| Title | Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | May 29, 2023 |
| Device classes | Class 1 |
| Scope (excerpt) | This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations. This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than… |
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: