PHR
8 FDA 510(k) clearances · Product code
318 daysmedian time to decision
1394 days90th percentile
8clearances measured
FDA profile
- Official device name
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3260
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SDF Pro (K250222) | Belport Company, Inc., Gingi-Pak | 2025-05-07 |
| Silver Fluoride Hypersensitivity Varnish (K241041) | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 |
| FAgamin® (K240059) | Tedequim Srl | 2024-05-16 |
| e-SDF (K240619) | Kids-E-Dental Llp | 2024-03-06 |
| Centrix FluoroSilver Silver Diamine Fluoride 38% (K222459) | Centrix, Inc. | 2023-10-27 |
| Black Diamond (K222323) | Elevate Oral Care, LLC | 2023-06-23 |
| Riva Star (K172047) | Sdi Limited | 2018-04-11 |
| SILVER DENTAL ARREST (K102973) | Cooley Consulting, Inc. | 2014-07-31 |
Track PHR automatically
Every clearance here is in the API, with alerts when new ones post.