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U.S. Department of Health and Human Services

Product Classification

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Device handpiece, belt and/or gear driven, dental
Regulation Description Dental handpiece and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEFA
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 872.4200
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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