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U.S. Department of Health and Human Services

Product Classification

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Device scaler, ultrasonic
Regulation Description Ultrasonic scaler.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeELC
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 872.4850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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