BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P000023 · Decision Jan 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
    PMA Number
    P000023
    Device Class
    FDA Class 3
    Product Code
    LZD
    Generic Name
    Joint, temporomandibular, implant
    Regulation Number
    872.3940
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 5, 2001
    Date Received
    June 20, 2000
    Expedited Review
    N
    Docket Number
    01M-0255

    Advisory Committee Statement

    APPROVAL FOR THE TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM. THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT. PATIENTS SHOULD BE CONSIDERED IF THEY HAVE ONE OR MORE OF THE FOLLOWING CONDITIONS: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 2) RECURRENT FIBROUS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 3) FAILED TISSUE GRAFT 4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION 5) LOSS OF VERTICAL MANDIBULAR HEIGHT AND/OR OCCLUSAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL RELATIONSHIP DUE TO BONE RESORPTION, TRAUMA, DEVELOPMENTAL ABNORMALITY, OR PATHOLOGIC LESION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZD Joint, Temporomandibular, Implant