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U.S. Department of Health and Human Services

Product Classification

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Device unit, electrosurgical, and accessories, dental
Regulation Description Dental electrosurgical unit and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEKZ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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