Diammine Silver Fluoride Dental Hypersensitivity Varnish
Regulation 872.3260
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Belport Company, Inc., Gingi-Pak | 1 | 0 |
| Centrix, Inc. | 1 | 0 |
| Cooley Consulting, Inc. | 1 | 0 |
| Elevate Oral Care, LLC | 1 | 0 |
| Kids-E-Dental Llp | 1 | 0 |
| Sdi Limited | 1 | 0 |
| Tedequim Srl | 1 | 0 |
| Young Dental Manufacturing Co. 1, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 7, 2025 | K250222 | SDF Pro Belport Company, Inc., Gingi-Pak | PHR |
| Feb 28, 2025 | K241041 | Silver Fluoride Hypersensitivity Varnish Young Dental Manufacturing Co. 1, LLC | PHR |
| May 16, 2024 | K240059 | FAgamin® Tedequim Srl, AR | PHR |
| Mar 6, 2024 | K240619 | e-SDF Kids-E-Dental Llp, IN | PHR |
| Oct 27, 2023 | K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% Centrix, Inc. | PHR |
| Jun 23, 2023 | K222323 | Black Diamond Elevate Oral Care, LLC | PHR |
| Apr 11, 2018 | K172047 | Riva Star Sdi Limited, AU | PHR |
| Jul 31, 2014 | K102973 | SILVER DENTAL ARREST Cooley Consulting, Inc. | PHR |
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