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U.S. Department of Health and Human Services

Product Classification

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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 CodePHR
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental 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
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