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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 Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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