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U.S. Department of Health and Human Services

Product Classification

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Device adhesive, bracket and tooth conditioner, resin
Regulation Description Bracket adhesive resin and tooth conditioner.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDYH
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.3750
Device Class 2
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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