FDA Product Code
FDA Product Code PHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3260
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | 2025-05-07 | Traditional | PDF ↗ |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 | Traditional | PDF ↗ |
| K240059 | FAgamin® | Tedequim Srl | 2024-05-16 | Traditional | PDF ↗ |
| K240619 | e-SDF | Kids-E-Dental Llp | 2024-03-06 | Traditional | PDF ↗ |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | 2023-10-27 | Traditional | PDF ↗ |
| K222323 | Black Diamond | Elevate Oral Care, LLC | 2023-06-23 | Traditional | PDF ↗ |
| K172047 | Riva Star | Sdi Limited | 2018-04-11 | Traditional | PDF ↗ |
| K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | 2014-07-31 | Traditional | PDF ↗ |
Product code PHR · Class II · Dental. Data: openFDA.