Medical Devices; Classification of Temporomandibular Joint Implants

요약

The Food and Drug Administration (FDA) is reproposing to classify two temporomandibular joint (TMJ) implants, the Mandibular Condyle Prosthesis and the Glenoid Fossa Prosthesis, into class III (premarket approval). The agency is issuing this reproposal to reflect the recommendation of the Dental Products Panel with respect to the classification of these devices. All comments received on the original proposal remain part of the record for this proposal. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments) and the Safe Medical Devices Act of 1990 (the SMDA).