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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 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 872.4200
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions
Third Party Review
Accredited Persons

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