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510(k) Data Aggregation

    K Number
    K081157
    Device Name
    ACCUFRAME
    Manufacturer
    CAGENIX INC.
    Date Cleared
    2008-07-22

    (90 days)

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

    CAGENIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accuframe™ is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
    Device Description
    Accuframe is a machined custom titanium framework for fabrication of multi-unit screwretained, cement-retained or combination of screw and cement-retained restorations with attachment at the abutment level. It is compatible with implants and abutments manufactured by Straumann, Nobel Biocare, Astra Tech, 3i and Zimmer.
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