BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P980052 · Supplement: S015 · Decision Aug 8, 2024
    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
    PMA Number
    P980052
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    LZD
    Generic Name
    Joint, temporomandibular, implant
    Regulation Number
    872.3940
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 8, 2024
    Date Received
    August 1, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    change of the current Process Challenge Device (PCD) used during the in-house 100% ethylene oxide (EO) sterilization of the Patient-Fitted TMJ Implants at the TMJ Concepts facility located in Ventura, CA

    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