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U.S. Department of Health and Human Services

Product Classification

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Device varnish, cavity
Regulation Description Cavity varnish.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeLBH
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)
Regulation Number 872.3260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons