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U.S. Department of Health and Human Services

Product Classification

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Device prophy powder, airbrush accessory
Regulation Description Airbrush.
Definition An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.
Physical State Powder
Technical Method The powder is dispensed via an electric airbrush and removes plaque via abrasion of the tooth surface by the powder granules.
Target Area Oral cavity
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePIP
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 872.6080
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