Product code
PHR: Diammine silver fluoride dental hypersensitivity varnish
FDA product code · Class II · Dental
Key facts
| Product code | PHR |
|---|---|
| Device | Diammine silver fluoride dental hypersensitivity varnish |
| Device class | Class II |
| Regulation number | 872.3260 |
| Review panel | Dental |
| Medical specialty | Dental |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database