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U.S. Department of Health and Human Services

Product Classification

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Device bracket, plastic, orthodontic
Regulation Description Orthodontic plastic bracket.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDYW
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 872.5470
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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