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510(k) Data Aggregation

    K Number
    K140432
    Device Name
    HI-LIGHT, HI-LIGHT PLUS
    Manufacturer
    DENTALL CORPORATION
    Date Cleared
    2015-08-03

    (529 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTALL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
    Device Description
    Hi-Light and Hi-Light plus are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 420~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.
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