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U.S. Department of Health and Human Services

Product Classification

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Device bracket, metal, orthodontic, reprocessed
Regulation Description Orthodontic appliance and accessories.
Definition Intended for use in orthodontic treatment.The device is affixed to a tooth so that pressure can be exerted on the teeth.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNQS
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 872.5410
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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