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510(k) Data Aggregation

    K Number
    K072807
    Device Name
    I LIGHT
    Manufacturer
    Date Cleared
    2007-11-21

    (51 days)

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

    DENT'N CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The I Light intraoral curing light is designed to polymerize visible light cure (VLC) dental materials, including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials.
    Device Description
    The I Light is a LED curing light that is small, easy to use, and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. It consists of a hand unit and a battery charger. The hand unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and an optical fiber that conducts light to the treatment area on the patient.
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