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510(k) Data Aggregation

    K Number
    K973410
    Device Name
    ULTRACAM
    Manufacturer
    Date Cleared
    1998-10-08

    (394 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    W. EDWARD JOHANSEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intraoral camera system, Ultracam, of Dental Vision Direct, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
    Device Description
    Ultracam, intraoral camera system and accessories
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