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U.S. Department of Health and Human Services

Product Classification

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Device joint, temporomandibular, implant
Regulation Description Total temporomandibular joint prosthesis.
Definition Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Physical State The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head right in front of the ear.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeLZD
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3940
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