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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?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242646
    Device Name
    Dental Implant Unit
    Manufacturer
    Guilin AestheDent Medical Instruments Co., Ltd
    Date Cleared
    2025-04-11

    (220 days)

    Product Code
    EBW, DAT
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
    Device Description
    The Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor.
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    K Number
    K233288
    Device Name
    NLZ Built-In Motor System
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2024-06-24

    (269 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
    Device Description
    The NLZ Built-in Motor System is a dental treatment system that is integrated and used in conjunction with dental chair units. It is composed of a motor system, a Multi-Pad, as well as a handpiece (optional) and cord that are compatible with different electric attachments The motor system has a control unit that works as an electric micromotor which can turn on or off and regulates the speed of the electric motor by the foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light. Depending on the specifications of each chair unit manufacturers, the combination and operation method of the NLZ Built-in Motor System board, harness, and operation method will change.
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    K Number
    K233117
    Device Name
    Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2024-06-20

    (267 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgic Pro2 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
    The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements. The Surgic Pro2 is intended for use in 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. Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad. * The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth. The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.
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    K Number
    K230895
    Device Name
    CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,
    Manufacturer
    CEFLA S.C.
    Date Cleared
    2024-04-01

    (367 days)

    Product Code
    EBW, EAQ, EBZ, PEQ
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.
    Device Description
    The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units. The CEFLA Dental Micromotors family presents two versions: 1) long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures: 2) short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is especially suitable for prosthetic & restorative procedures. Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques. Furthermore, both versions of micro-motors are intended to be connect with the following two parts: 1) CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board; 2) handpieces which transmit movement to their tips or other instrument, legally marketed in USA. The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.
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    K Number
    K231864
    Device Name
    Fiber Optic Brushless Electronic Micromotor, model: iM100
    Manufacturer
    Codent Technical Industry Co., Ltd.
    Date Cleared
    2024-03-11

    (259 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.
    Device Description
    The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.
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    K Number
    K211358
    Device Name
    Implanter incl. Accessories
    Manufacturer
    Guilin Woodpecker Medical Instrument Co., Ltd.
    Date Cleared
    2022-11-21

    (567 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
    Device Description
    The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
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    K Number
    K220831
    Device Name
    Dental Implantation Systems, Dental Electrical Motors
    Manufacturer
    Foshan COXO Medical Instrument Co., Ltd.
    Date Cleared
    2022-09-27

    (189 days)

    Product Code
    EBW, EGS, KMW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C-Sailor Pro: This device 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. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER: The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth. This device is designed for use by a trained professional in the filed of general dentistry.
    Device Description
    The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation. The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.
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    K Number
    K213022
    Device Name
    CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
    Manufacturer
    CEFLA S.C.
    Date Cleared
    2022-05-09

    (231 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.
    Device Description
    The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units. The CEFLA Dental Micromotors family presents two versions: 1) long version (long) with Led light, especially suitable for implant & endodontic procedures; 2) short version (short) with optional Led light, especially suitable for prosthetic & restorative procedures. Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques. Furthermore, both versions of micro-motors are intended to be connect with the following two parts: 1) CEFLA Dental Unit, legally marketed in USA, thought a cord for connection between micromotor and the dental unit system including electronic board; 2) handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
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    K Number
    K202075
    Device Name
    Dental Electric Motor
    Manufacturer
    Foshan CICADA Dental Instrument Co, Ltd.
    Date Cleared
    2022-03-11

    (592 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EBW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm. The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction. The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center. The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
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