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510(k) Data Aggregation

    K Number
    K013271
    Device Name
    DXS DIGITAL X-RAY SYSTEM
    Date Cleared
    2001-12-13

    (73 days)

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

    DOUGLAS C. YOON, DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An extraoral 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
    An extraoral source x-ray system which is a host PC powered device that produces digital radiographs.
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