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510(k) Data Aggregation

    K Number
    K091051
    Device Name
    BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
    Manufacturer
    TITA-LINK
    Date Cleared
    2009-12-08

    (239 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    TITA-LINK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.
    Device Description
    The Bollard Miniplate Skeletal Anchorage System provides a fixed anchorage point for the attachment of orthodontic appliances to facilitate orthodontic movement of teeth. Small stationary points connected to bone inside the mouth allow connection of wire, elastic, or other hardware. The Bollard Miniplate Skeletal Anchorage System includes Commercially Pure Titanium miniplates fixed by miniscrews to the cortical bone. After insertion by the surgeon the miniplates are completely covered by soft tissue. The miniplates and miniscrews are sold sterile and are sterilized using Gamma Radiation per ISO 11137-1. The bone anchor consists of a miniplate (M) with 2 or 3 holes, a round connecting bar (C), and a fixation unit (F) with a blocking screw (S). The miniplate is fixed to the bone by self-tapping or selfdrilling screws. The fixation unit contains 2 slots with a diameter of 0.045" (1.1mm). A square connecting wire with a maximum size of 0.032x0.032" can be inserted and tightly fixed by the blocking screw. The Bollard miniplates are also offered with a hook. The Bollard with hook is smaller than the original model and contains a tube with section 0.020"x0.020". The hook can affix directly to elastics or coil springs. The subject devices are used with standard instrumentation for orthodontic surgery including pliers, punches, screwdrivers, burrs, and grasping or holding instruments.
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