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510(k) Data Aggregation

    K Number
    K022020
    Device Name
    JUSTWO MODEL TME-601 ROOT APEX LOCATOR
    Manufacturer
    TOEI ELECTRIC CO., LTD.
    Date Cleared
    2002-07-02

    (12 days)

    Product Code
    LQY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOEI ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
    Device Description
    The subject device is a lightweight, fully-automatic, batteryoperated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 500 Hz and 2000 Hz. The current between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal. The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.
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    K Number
    K021374
    Device Name
    TOESCO AQUA BLUE LED LIGHT CURING DEVICE
    Manufacturer
    TOEI ELECTRIC CO., LTD.
    Date Cleared
    2002-05-30

    (29 days)

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

    TOEI ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.
    Device Description
    The Toesco Aqua Blue Led Light Curing Device is a gun-handle shaped dental curing light that is intended to polymerize dental materials such as resins and sealants by transmitting light through a light guiding tip. The source of blue light is a light-emitting diode. The device has two optional curing modes: two full power modes and a 2-step curing mode. It incorporates three pre-set programs and seven user programs. The power source is a 7.4 V Lithium Ion Battery. Wavelength is 450 nm - 480 nm, with wavelength peaking at 470nm.
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    K Number
    K972407
    Device Name
    ROOT APEX LOCATOR
    Manufacturer
    TOEI ELECTRIC CO., LTD.
    Date Cleared
    1997-09-11

    (77 days)

    Product Code
    LQY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOEI ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.
    Device Description
    The subject device is a lightweight, fully-automatic, battery-operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 500 Hz and 2000 Hz. The impedance between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal. The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.
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