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510(k) Data Aggregation

    K Number
    K152936
    Device Name
    Sirius Max Dental Diode Curing Light
    Manufacturer
    NATIONAL DENTAL INC.
    Date Cleared
    2015-11-13

    (39 days)

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

    NATIONAL DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sirius Max Diode Curing Light is intended for use as a source of illumination for photo initiated curing and/or activation/ polymerization of dental restorative materials and adhesives.
    Device Description
    The Sirius Max Diode Curing Light is shipped as a system consisting of the charging station ("charger"), the handpiece, 50 SiriusMax Barrier Sleeves, an orange protective eye shield, and screwdriver for removal of the battery. The charger allows for placement of the handpiece in a holder with electrical connection for battery charging and interface with the 5vdc power source. The handpiece is constructed of aluminum with plastic control surface and glass output lens and is non-sterile utilizing the barrier sleeves for infection control. The handpiece houses the control circuitry with microprocessor and user interface for selection of mode and curing light output providing visual indications of power settings and of the unit's status. This interface also features the unit's power ON/OFF switch as well as the button to activate the white light intraoral illumination light to aid in the visualization of dental anatomy. The unit is battery operated and contains an internal battery pack with Li batteries. The battery pack is service removable with the use of the screwdriver provide. An instruction for use is also included inside the packaging. The Instructions For Use detail the function of the device and describe the 6 different curing modes. They are Normal mode 1200mw/cm2, Softstart mode 1400mw/cm2, Pulse mode 1400mw/cm2, High Power mode 1300 mw/cm2, Xtra Power mode, 3000mw/cm2, and Orthodontics mode 1400mw/cm2. The curing LED module provides high intensity light in the range of 430-490nm. The white light transillumination LED module (400-700nm) is provided as an aid for illuminating anatomy in the oral cavity.
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