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510(k) Data Aggregation

    K Number
    K151588
    Device Name
    maxFit II Dental Implant System
    Date Cleared
    2016-04-25

    (319 days)

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

    Taiwan Implant Technology Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
    Device Description
    The maxFiT II Dental Implant System includes implant, screw and abutment. The maxFiT II Dental Implant System is designed for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The maxFiT II Dental Implant System consists of solid threaded, self-tapping dental implants in Ø3.5."604."70."5.6mm diameters with 8."32."34."14mm lengths. The implant of maxFiT II Dental Implant System is made from CP titanium Grade 4 which complies with ISO 5832-2 and ASTM F67. The implant surface treatment is SLA (Sand-blasted, Large grit, Acid -etched) technology which involves sandblasting with large grit and acid etching techniques, creates micron and macrosubmicron pores morphology. The abutments are made of Ti6A14V Eli, which complies with ISO 5832-3 and ASTM F136.
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