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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 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 872.4920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons