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510(k) Data Aggregation

    K Number
    K992102
    Device Name
    LUMA LIGHT 2000 CURE LIGHT
    Manufacturer
    LUMA LITE, INC,
    Date Cleared
    1999-08-31

    (71 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMA LITE, INC,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems. The Luma Light 2000 Cure Light cures all photo activated dental materials such as those used in direct restorations, sealants, bonding agents and primers.
    Device Description
    The Luma Light 2000 Cure Light is a high intensity filtered light source, and optical delivery system, that produces curing of photo-activated dental or photo-activated bleaching formulations at four (4) times the rate of conventional light systems.
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