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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible