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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 Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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