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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5410
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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