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U.S. Department of Health and Human Services

Product Classification

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Device interarticular disc prosthesis (interpositional implant)
Regulation Description Interarticular disc prosthesis (interpositional implant).
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMPJ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3970
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standard
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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