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510(k) Data Aggregation

    K Number
    K062735
    Device Name
    TUTU 7, MODEL IV-T22
    Date Cleared
    2006-10-27

    (44 days)

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

    INVISIBLE TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TUTU ™ LED 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 TuTu7 is a LED curing light that is small and easy to use, vet powerful 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. The TuTu has 3 different functioning modes, continuous, pulse and ramp. The device peeps every 3 seconds for precise timing of exposure, regardless of mode setting. The rechargeable battery is a Lithium lon, which at full charge can last up to 120 minutes. The TuTu is provided with a battery charger, which also acts as a storage holder for the device. A silicone sheath is provided to refract the light and protect the eyes of the operator.
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