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510(k) Data Aggregation

    K Number
    K113263
    Device Name
    ARGES IMAGING CONTRAST SPRAY
    Manufacturer
    ARGES IMAGING, INC
    Date Cleared
    2011-11-14

    (10 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARGES IMAGING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
    Device Description
    The Arges Imaging Contrast Spray is a pigment suspension in ethanol with a fluorinated hydrocarbon propellant. The Arges Imaging Contrast Spray is a coating medium which is applied to teeth and surrounding areas. A 3D impression of the coated dentition is taken using a commercially available CAD/CAM system. Upon completion of the impression scan, the patient's mouth if rinsed and suctioned to remove the Arges Imaging Contrast Spray.
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