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510(k) Data Aggregation

    K Number
    K093705
    Device Name
    FUORECAM
    Date Cleared
    2010-04-23

    (143 days)

    Product Code
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERAPEUTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FluoreCam™ is intended to be used as an aid in the diagnosis of dental caries. The FluoreCam™ is indicated as an aid in the diagnosis of dental caries.
    Device Description
    The FluoreCam™ consists of a handheld instrument that interfaces with custom computer software via a USB connection. The instrument excites the surface of a tooth with light and transmits images of the surface to the software. The software quantifies carious activity using the auto fluorescent property of tooth enamel.
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