BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P020016 · Supplement: S004 · Decision Jan 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
    PMA Number
    P020016
    Supplement Number
    S004
    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 29, 2010
    Date Received
    December 2, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PACKAGING MATERIALS OF BOTH THE FOSSA AND THE MANDIBULAR TMJ SYSTEM COMPONENTS, AND EXTENSION OF THE SHELF LIFE OF THESE DEVICES TO 5 YEARS.

    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