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510(k) Data Aggregation

    K Number
    K142813
    Device Name
    Biogensis Implant System-Kisses
    Manufacturer
    BIOGENESIS CO., LTD.
    Date Cleared
    2015-07-31

    (305 days)

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

    BIOGENESIS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biogenesis Implant System –Kisses is in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System - Kisses is for single and two stage surgical procedures. It is for delayed loading.
    Device Description
    The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial tooth and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. The Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length. The Biogenesis TM Implant System also offers the following components. - · Duplex Abutment - Duplex Milling Abutment - Simplex Abutment - Temporary Abutment - · Solid Screw Abutment - · Ball Abutment - Ball Cap The implants are intended for use with straight implant only straight implants are included in the submission.
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    K Number
    K120089
    Device Name
    BIOGENESIS IMPLANT SYSTEM
    Manufacturer
    BIOGENESIS CO., LTD.
    Date Cleared
    2013-03-13

    (427 days)

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

    BIOGENESIS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biogenesis Implant System - Aticon 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 terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
    Device Description
    The Biogenesis™ Implant System replaces the root of a missing tooth and is made from surgical grade titanium alloys. The Biogenesis™ Implant System is comprised of two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture.
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