PHR
- Product code
- PHR
- Device name
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3260
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250222 | 2025-05-07 | Belport Company, Inc., Gingi-Pak | SDF Pro | — |
| K241041 | 2025-02-28 | Young Dental Manufacturing Co. 1, LLC | Silver Fluoride Hypersensitivity Varnish | |
| K240059 | 2024-05-16 | Tedequim Srl | FAgamin® | |
| K240619 | 2024-03-06 | Kids-E-Dental Llp | e-SDF | FDA |
| K222459 | 2023-10-27 | Centrix, Inc. | Centrix FluoroSilver Silver Diamine Fluoride 38% |
Official FDA classification page: PHR
Classification and pathway per current FDA publications. Data from openFDA (CC0).