Product Classification

• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc