BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P980052 · Supplement: S017 · Decision Mar 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
    PMA Number
    P980052
    Supplement Number
    S017
    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
    March 6, 2026
    Date Received
    July 28, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the implementation of two (2) new sterile barrier heat sealing machines for use in the packaging process of patient-fitted TMJ implant

    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