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U.S. Department of Health and Human Services

Product Classification

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Device headgear, extraoral, orthodontic
Regulation Description Extraoral orthodontic headgear.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDZB
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 872.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons