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U.S. Department of Health and Human Services

Product Classification
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Device mandibular condyle prosthesis
Regulation Description Mandibular condyle prosthesis.
Definition PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98))
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMPL
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3960
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 Standards
Third Party Review Not Third Party Eligible
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