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U.S. Department of Health and Human Services

Product Classification

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Device external cleaning solution
Regulation Description Cavity varnish.
Definition For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Physical State Solution consists of a gel or liquid that is applied directly to the dental restoration.
Technical Method Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
Target Area The target area of the body is a tooth which will have the dental restoration applied to it.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePME
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible