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

    Joint, Temporomandibular, Implant

    PMA: P980052 · Supplement: S012 · Decision Aug 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st
    PMA Number
    P980052
    Supplement Number
    S012
    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 22, 2023
    Date Received
    August 4, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of SAP ERP System to replace Factory Edge

    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