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U.S. Department of Health and Human Services

Product Classification

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Device handpiece, direct drive, ac-powered
Regulation Description Dental handpiece and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEKX
Premarket Review 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
Third Party Review
Accredited Persons
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