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510(k) Data Aggregation

    K Number
    K013690
    Device Name
    IDENT-A100 INTRAORAL VIDEO CAMERA
    Date Cleared
    2002-01-30

    (84 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONFIDENT TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iDENT-A100 Intraoral video camera of the Confident Technology Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his/her mouth showing the patient results of the dental procedures which the dentist has performed on him/her. These are not intended to aid in dental surgical procedures.
    Device Description
    The iDENT-A100 Intraoral Video Camera provides clear, high resolution images of the oral cavity, which can be stored and manipulated in the built digital memory and used for visual communication directly to the patient. The System can capture one full image or can capture four images into one frame and the captured images can be display on a video monitor. The operation of the capturing image can be done by a foot switch or a push button and is very user-friendly. The typical dentist and assistant can use the system with a few minutes training. A high resolution, true color image is produced on the screen by a rod lens scope design which is the standard in the industry for endoscopic procedures. There is no peripheral distortion of the image. Manual focusing is not required and a single tooth or full arch view can be captured without changing the scope. The unit is easily detached for autoclaving cleaning.
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