BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P980052 · Supplement: S002 · Decision Jan 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
    PMA Number
    P980052
    Supplement Number
    S002
    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 14, 2003
    Date Received
    November 27, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE STERILE PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TO BE STERILIZED AT TMJ CONCEPTS, VENTURA, CALIFORNIA.

    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