Recognized standard
17730 Third edition 2025-09 Standard No. 117-2022
FDA recognition 4-354 · ISO · Dental/ENT
Key facts
| Recognition number | 4-354 |
|---|---|
| Designation | 17730 Third edition 2025-09 Standard No. 117-2022 |
| Title | Dentistry - Fluoride varnishes Dentistry - Fluoride Varnishes |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. This also specifies… |
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: