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510(k) Data Aggregation

    K Number
    K070373
    Device Name
    APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2007-03-02

    (22 days)

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

    APOZA ENTERPRISE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APOZA LED Curing Light is a dental curing light that is designed for use in the optical polymerization of dental resins.
    Device Description
    APOZA LED Curing Light (Family: Model# E-Morl.it , D-2000 , TOP 3W, TOP 5W) is non-invasive medical device and is designed for use in the optical polymerization of dental resins. APOZA LED Curiing Light deliver 440-490nm blue light. APOZA LED Curing Light is also called APOZA Dental Curing Light. it includes the following models: . E-MorLit consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) , () D-2000 consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) () TOP 3W consist of a handy unit and a switching power adaptor. () TOP 5W consist of a handy unit and a switching power adaptor. The handy unit contains a programmed control circuit, high intensity dental blue LEI》 light source, a light quide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
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    K Number
    K041303
    Device Name
    LED TURBO-PEN
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2004-06-18

    (32 days)

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

    APOZA ENTERPRISE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
    Device Description
    The LED Turbo-Pen consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate. timing and monitoring the temperature of the LED.
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    K Number
    K033198
    Device Name
    APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2004-04-30

    (211 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    APOZA ENTERPRISE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth er clean the root canal ( with endo-kit) in the prophylaxis procedures.
    Device Description
    Not Found
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    K Number
    K040618
    Device Name
    LED TURBO
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2004-03-25

    (16 days)

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

    APOZA ENTERPRISE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Turbo is a dental curing light that is designed for use in the polymerization of dental resins and the activation of bleaching materials.
    Device Description
    The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
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    K Number
    K033201
    Device Name
    LA500 BLUE LIGHT
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2003-12-02

    (61 days)

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

    APOZA ENTERPRISE CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LA500 Blue Light is a visible curing unit programmed for This polymerization of light cured materials by dental professionals..
    Device Description
    APOZA CURING LIGHT, Models: LA500 Blue Light. The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.
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