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510(k) Data Aggregation

    K Number
    K212702
    Device Name
    IM/ST Fixture System
    Date Cleared
    2022-10-13

    (413 days)

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

    Guilin FiTeeth Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IM/ST Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
    Device Description
    The proposed device, IM/ST Fixture System, is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant system contain dental implant and abutment. The dental implant system, IM Implant System and ST Implant System, both of which are divided into mini implant and regular implant. IM Implant and ST Implant have different designs for the external thread section. The external thread part of IM implant is composed of conical shape, double thread and spiral groove, while The external thread part of ST implant is composed of conical shape, single thread, neck micro thread and cutting groove. Both IM implant and ST implant are available in diameters of 3.75, 4.2, 4.6 and 5.05mm and lengths of 7, 8.5, 10, 11.5, 13 and 15mm, and both are bone level. The "mini" and "regular" differ in size, but abutments are cross-compatible with both IM and ST implant types, and the abutment is attached to the implant by abutment screw and fastened to the implant. The material of abutment screw is Titanium Alloy (Ti-6A1-4V, ASTM F136). The implants are bone level. The implants were made of Pure Titanium Grade 4 and underwent sandblasting and acid etching process. Modified surface testing (SEM/EDS) for blasted/etched surfaces was conducted to demonstrate removal of particles and chemicals from implant surface. Abutment can be divided into healing abutment, straight abutment, multi-abutment, multi-angled abutment and temporary abutment. And it is divided into mini abutment and regular abutment. In addition, abutment also has three types of cylinder, angled cylinder and temporary cylinder.
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