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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
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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