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510(k) Data Aggregation

    K Number
    K990049
    Device Name
    CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000
    Manufacturer
    Date Cleared
    1999-03-12

    (64 days)

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

    DIGIDENT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.
    Device Description
    The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital intraoral, extraoral and cephalometric radiography using a phosphor storage screen. They enable the dentist to scan or import images for display, review or storage in a database. They consist of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a userprovided personal computer.
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