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510(k) Data Aggregation

    K Number
    K050515
    Device Name
    BONE BLOCK FIXATION SET
    Manufacturer
    STRAUMANN USA, INC.
    Date Cleared
    2005-04-05

    (35 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRAUMANN USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Straumann Bone Block Fixation is used to stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity. The bone grafting fixation technique can make it possible for the placement of dental implants in previously unsuitable sites.
    Device Description
    Straumann Bone Block Fixation includes a cassette, instruments, and screws that are slight modifications of ones previously cleared by FDA under K011698. Modification to the instruments and screws are in dimensions only.
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