Device |
diammine silver fluoride dental hypersensitivity varnish |
Regulation Description |
Cavity varnish. |
Definition |
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity. |
Physical State |
liquid, gel |
Technical Method |
precipitates upon application resulting in a physical blockage of dentinal tubules |
Target Area |
tooth enamel |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | PHR |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.3260
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|