Recognized standard
Standard No. 117-2018
FDA recognition 4-280 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-280 |
|---|---|
| Designation | Standard No. 117-2018 |
| Title | Fluoride varnishes |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements and their test methods for total digestible fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: