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 | ||
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Manufacturer | Decision | |
COOLEY CONSULTING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SDI LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 |