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    K Number
    K131258
    Device Name
    SATURN DENTAL IMPLANT
    Manufacturer
    CORTEX DENTAL IMPLANTS INDUSTRIES, LTD
    Date Cleared
    2014-03-17

    (319 days)

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

    CORTEX DENTAL IMPLANTS INDUSTRIES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading. The procedure can be accomplished in a one-stage or two-stage surgical operation.
    Device Description
    The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined. SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading. The SATURN Dental Implant System is cleared for marketing in Europe. The device was implanted in thousands of patients in Israel and Europe. Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. Function: The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading. The procedure can be accomplished in a one-stage or two-stage surgical operation.
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    K Number
    K090709
    Device Name
    CORTEX DENTAL IMPLANT SYSTEM
    Manufacturer
    CORTEX DENTAL IMPLANTS INDUSTRIES, LTD
    Date Cleared
    2009-07-07

    (111 days)

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

    CORTEX DENTAL IMPLANTS INDUSTRIES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
    Device Description
    The Cortex Dental Implant System includes an integral array of devices comprising mainly of dental implants, abutments, additional prosthetic and surgical components, post surgical components, and surgical instruments.
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