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510(k) Data Aggregation

    K Number
    K043068
    Device Name
    DIFOTI USB 2.0 SYSTEM
    Manufacturer
    ELECTRO-OPTICAL SCIENCES, INC.
    Date Cleared
    2004-12-29

    (51 days)

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

    ELECTRO-OPTICAL SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
    Device Description
    The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.
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    K Number
    K991098
    Device Name
    DIFOTI SYSTEM
    Manufacturer
    ELECTRO-OPTICAL SCIENCES, INC.
    Date Cleared
    1999-06-30

    (90 days)

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

    ELECTRO-OPTICAL SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.
    Device Description
    The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,
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