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    K Number
    K080738
    Device Name
    DENTRON SENSOR
    Manufacturer
    DENTRON SYSTEMS LLC
    Date Cleared
    2008-05-13

    (57 days)

    Product Code
    EAP
    Regulation Number
    872.1810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTRON SYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
    Device Description
    The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.
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