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

    Glenoid Fossa Prosthesis

    PMA: P000035 · Supplement: S010 · Decision May 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Glenoid Fossa Prosthesis
    Trade Name
    TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM
    PMA Number
    P000035
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MPI
    Generic Name
    Glenoid fossa prosthesis
    Regulation Number
    872.3950
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 21, 2014
    Date Received
    May 2, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD WATER QUALITY STANDARDS.

    Classifications

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

    Product Code Device Name
    MPI Glenoid Fossa Prosthesis