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510(k) Data Aggregation

    K Number
    K202963
    Device Name
    ELEC Master, ELEC Master Dual
    Manufacturer
    Mgnewton Ltd.
    Date Cleared
    2023-05-05

    (947 days)

    Product Code
    EIA, EBW
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mgnewton Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.
    Device Description
    This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.
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    K Number
    K202965
    Device Name
    CURA-Temp
    Manufacturer
    Mgnewton LTD.
    Date Cleared
    2022-12-21

    (812 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mgnewton LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
    Device Description
    This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.
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