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U.S. Department of Health and Human Services

Product Classification

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Device unit, operative dental
Regulation Description Dental operative unit and accessories.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEIA
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 872.6640
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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