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510(k) Data Aggregation

    K Number
    K033147
    Device Name
    CLEARTOOTH DIGITAL X-RAY SYSTEM
    Date Cleared
    2003-12-30

    (91 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEARTOOTH ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.
    Device Description
    The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.
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