BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Joint, Temporomandibular, Implant

    PMA: P000023 · Supplement: S007 · Decision Jun 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Joint, Temporomandibular, Implant
    Trade Name
    TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM
    PMA Number
    P000023
    Supplement Number
    S007
    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
    June 27, 2012
    Date Received
    August 29, 2011
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ MEDICAL IN GOLDEN, COLORADO.

    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