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510(k) Data Aggregation

    K Number
    K231562
    Device Name
    ELEC ENGINE (Model: ISE-170L)
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2025-07-18

    (779 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K232810
    Device Name
    Dental Handpiece, Wireless Endodontic Handpiece, endoit
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2023-11-09

    (58 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
    Device Description
    Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
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    K Number
    K220577
    Device Name
    Dental Handpiece, Model CA160, CA160L, and CA500L
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2022-07-29

    (151 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.
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    K Number
    K201191
    Device Name
    ELEC-LED
    Manufacturer
    MICRO-NX Co., Ltd.
    Date Cleared
    2022-02-07

    (644 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
    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 spinning direction through the motor control circuit inside the controller. Motor speed, motor operating mode, light and spinning direction functions can be set on the display panel. The operating mode of the motor is composed of three modes: HD (Hand control mode), PP (Press pedal mode) and EP (Electric pedal mode).
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    K Number
    K201192
    Device Name
    Impla-NX (Model: ISE-270M)
    Manufacturer
    MICRO-NX Co., Ltd.
    Date Cleared
    2021-05-21

    (382 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impla-NX (Model: ISE-270M) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
    Device Description
    As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control. With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.
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    K Number
    K192809
    Device Name
    Dental Handpiece
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2020-08-25

    (329 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro-NX Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments). Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors" The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.
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