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510(k) Data Aggregation

    K Number
    K200597
    Device Name
    Straumann BLX Gold Abutments
    Manufacturer
    Straumann USA, LLC (On behalf of Institut Straumann AG)
    Date Cleared
    2020-08-19

    (163 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Straumann USA, LLC (On behalf of Institut Straumann AG)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.
    Device Description
    The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs. The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.
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