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510(k) Data Aggregation

    K Number
    K170529
    Device Name
    Delight, Delight ortho, B&Lite S
    Manufacturer
    DENTALL Co., Ltd.
    Date Cleared
    2017-08-08

    (167 days)

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

    DENTALL Co., Ltd.

    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
    Delight, Delight ortho and B&Lite S 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 430~490nm 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. The device is not provided sterile and is not intended to be sterilized when used. To prevent cross contamination, users must cover the device with FDA cleared barrier sheath (K132953/ TIDIShield™ Curing Light Sheath). It should be changed between each patient.
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