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510(k) Data Aggregation

    K Number
    K052840
    Device Name
    IGI-SYSTEM
    Manufacturer
    DENX ADVANCED DENTAL SYSTEMS
    Date Cleared
    2005-12-16

    (70 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENX ADVANCED DENTAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IGI-System™, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure. The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.
    Device Description
    System enabling image guided surgery for dental implant surgery through the utilization of planning software based on patient CT, registration through the use of fiducial markers and real time navigation by tracking both patient and handpiece movement and comparing to the pre-defined surgery plan.
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    K Number
    K023424
    Device Name
    IGI-SYSTEM
    Manufacturer
    DENX ADVANCED DENTAL SYSTEMS
    Date Cleared
    2003-05-09

    (210 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENX ADVANCED DENTAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IGI Image-Guided Implantation system, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.
    Device Description
    The IGI-System is an electro-optical device, which was specifically designed to greatly improve the surgical implantation procedure by providing the surgeon an accurate guidance to the location of the surgical tools prior to, and more importantly, during the surgical operation. The novel device both increases surgical success rate, and reduces potential damage to adjacent anatomical structures and tissues. The IGI-System introduces, for the first time, the element of objective, state-of-the-art measurements to the field of dental implantation. Equipped with the IGI-System, the dental surgeon is able to plan the implantation procedure and align the actual placement of the implant in the pre-planned position with great accuracy. The IGI-System allows the user to view the reconstructed 2D images of the patient anatomy together with overlaid graphic information depicting the position of dental surgical instrument and pre-planned position of dental implant. The IGI-System utilises an infra-red (IR) optical tracking system, comprised of emitters, camera and a tracking data processor (computer), to determine the location and orientation of the dental hand-piece and the patient. The position and orientation of both the dental surgical instrument and the patient are transmitted to an image data processor (computer) which makes necessary calculations to provide the guidance graphic overlay depicting the dental surgical instrument and planned dental implant location on the medical image. Alignment of the patient and medical images is accomplished through a process termed fiducial registration. The goal is to indicate to the dentist, based on the preimplantation medical images, the exact position of the tracked dental surgical instrument together with the location of planned dental implant location, with regard to the patient's anatomy. The dentist will place a virtual implant image in the optimal location by use of the IGI software and available CT data. Once an implant has been optimally positioned, the system will correlate between the dentist's plan and the actual performance. In case of significant variance between the plan and the performance the system will alert the user. The system is used in two stages of the implantation procedure. The first stage is preplanning of the surgical implantation procedure. The second stage is the clinical one in which the system is used for accurate guidance of dental surgical instruments according to the pre-planned implant position. In addition, the system assists the dentist in avoiding critical anatomical structures. The system is used to pre-plan the surgical implantation procedure. Consequently, the system provides accurate guidance during the dental implantation, of surgical instruments with regard to pre-operative planning, and assists the dentist in avoiding the risk of causing damage to critical anatomical structures. The IGI-System is defined as a supporting device, providing a significant contribution to the decision-making process, which continuously takes place during the implantation process. It is by no means intended to replace human judgement. The final decisions as to the exact location, timing, intensity and depth of the drilling are the sole responsibility of the surgeon. The surgeon is at liberty, at any time throughout the surgical procedure, to determine the final drilling position, or to modify implants' planned position. Thus, under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.
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