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510(k) Data Aggregation

    K Number
    K033795
    Device Name
    PLASMACURE BXE
    Manufacturer
    EELE LABORATORIES, LLC
    Date Cleared
    2003-12-19

    (14 days)

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

    EELE LABORATORIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
    Device Description
    The PlasmaCure BXe is a device used for the polymerization of dental materials using blue light. It consists of a base unit and a cord connected hand piece. The molded plastic control unit (base unit) contains a power inlet receptacle for a detachable mains power cord, fuse holder and fuses, power supply & controller printed circuit board (control circuitry for lamp and cooling fan functions). The cord connected hand piece contains a printed circuit board, lamp reflector module assembly, optical filter assembly, fibertip insert and fiber optic tip that generates blue light energy having the wavelength range of approximately 385-495 nm. An external trigger switch (hand piece) activates the curing lamp. The emitted intensity and exposure time level depends on which type of eeleCoolTip™ is inserted in the hand piece and which key was last activated on the keypad of the base unit. The hand piece also has a removable and rotatable light shield that will protect the user when in operation.
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