Definition: Applied To Tooth Enamel To Block Dentinal Tubules For The Purpose Of Reducing Tooth Sensitivity.
| Device Type ID | 1379 |
| Device Name | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Physical State | Liquid, Gel |
| Technical Method | Precipitates Upon Application Resulting In A Physical Blockage Of Dentinal Tubules |
| Target Area | Tooth Enamel |
| Regulation Description | Cavity Varnish. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.3260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1379 |
| Device | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Product Code | PHR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cavity Varnish. |
| CFR Regulation Number | 872.3260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOLEY CONSULTING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SDI LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |