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U.S. Department of Health and Human Services

Product Classification

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Device prophy powder, airbrush accessory
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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.6080
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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