FDA product code PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish
PHR is the FDA product code for diammine silver fluoride dental hypersensitivity varnish. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under PHR, 6 in the last five years, from 8 different applicants. The average 510(k) review took 373 days (median 298); 137 days on average over the last three years.
Definition
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Classification
| Field | Value |
|---|---|
| Device name | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Device class | Class II |
| Regulation | 21 CFR 872.3260 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PHR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 279 |
| 2023 | 2 | 382 |
| 2024 | 2 | 65 |
| 2025 | 2 | 209 |
Compare with all 510(k) review times · Search every PHR clearance
Top PHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Belport Company, Inc., Gingi-Pak | 1 | 2025-05-07 |
| Young Dental Manufacturing Co. 1, LLC | 1 | 2025-02-28 |
| Tedequim Srl | 1 | 2024-05-16 |
| Kids-E-Dental Llp | 1 | 2024-03-06 |
| Centrix, Inc. | 1 | 2023-10-27 |
3 more applicants have PHR clearances. See the full list in Caduvo.
Most recent PHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250222 | Belport Company, Inc., Gingi-Pak | SDF Pro | 2025-05-07 | 100 |
| K241041 | Young Dental Manufacturing Co. 1, LLC | Silver Fluoride Hypersensitivity Varnish | 2025-02-28 | 318 |
| K240059 | Tedequim Srl | FAgamin® | 2024-05-16 | 129 |
| K240619 | Kids-E-Dental Llp | e-SDF | 2024-03-06 | 1 |
| K222459 | Centrix, Inc. | Centrix FluoroSilver Silver Diamine Fluoride 38% | 2023-10-27 | 438 |
Recalls for PHR devices
openFDA lists no recalls for product code PHR.
Frequently asked questions
What is FDA product code PHR?
PHR is the FDA product code for diammine silver fluoride dental hypersensitivity varnish. It is a Class II device, regulated under 21 CFR 872.3260 and reviewed by the Dental panel.
What device class is PHR?
Class II, regulation 21 CFR 872.3260. Typical premarket route: 510(k).
How long does a 510(k) take for product code PHR?
Across 8 cleared submissions the average was 373 days from receipt to decision (median 298).
Which companies have the most PHR clearances?
Belport Company, Inc., Gingi-Pak (1); Young Dental Manufacturing Co. 1, LLC (1); Tedequim Srl (1); Kids-E-Dental Llp (1); Centrix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PHR
- Run a recall and safety report across every PHR manufacturer
- Watch product code PHR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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