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510(k) Data Aggregation

    K Number
    K983120
    Device Name
    BICORTICAL SCREW
    Manufacturer
    ORALTRONICS MARKETING-UND VERTRIEBS GMBH
    Date Cleared
    1999-07-29

    (328 days)

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

    ORALTRONICS MARKETING-UND VERTRIEBS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bicortical Screw is intended for surgical placement in edentulous anterior regions of the maxillary and/or mandibular arch to support crowns, bridges, or overdentures. In many cases the Bicortical Screw is inserted immediately after extraction.
    Device Description
    The Bicortical Screw is a self-tapping, single-stage titanium implant that enjoys maximum primary support in the bone, i.e., bicortical support. The high degree of initial stabilization on insertion ensures undisturbed healing for this free-standing implant site is prepared with a small diameter pilot bur and the screw implant cuts its own thread configuration, leaving only a very small wound. The implant is intended for sale in the United States with a square head and round head in two thread diameters each (3.5 mm and 4.5 mm major diameter). The square head version is bendable at the head whereas the round head version is not bendable.
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