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    K Number
    K072643
    Device Name
    CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US
    Manufacturer
    OLYMPUS CORPORATION
    Date Cleared
    2007-11-16

    (59 days)

    Product Code
    KZN
    Regulation Number
    872.3661
    Why did this record match?
    Product Code :

    KZN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Crystaleye Spectrophotometer/Crystaleye Basic Set CE100-DC/US is intended for use in automated color shade-matching to assist in dental restoration. The targeted teeth for color analysis are the left and right central incisors, lateral incisors and canines.
    Device Description
    The Crystaleye Device is an automated color shade-matching device, based upon a database of reference tooth shades. The Crystaleye Device is comprised of the following components: Spectrophotometer, AC Adapter, Cradle, Contact Cap (5 pcs.), AC Cable, USB Cable, Master CDs, and Instructions. A personal computer is also required to run the Master CDs. The reference color tooth shades of multiple dental restoration manufacturers are loaded into the computer. The spectrophotometer captures an image of the target tooth, and the software matches a patient's color tooth shade with the closest available shade in the computerized reference database.
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