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510(k) Data Aggregation

    K Number
    K242514
    Device Name
    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
    Manufacturer
    Shenzhen Rogin Medical Co., Ltd.
    Date Cleared
    2025-04-24

    (244 days)

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

    Shenzhen Rogin Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.
    Device Description
    ### E-LITE MAX & ELITE-INO: The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable. There are three function features for E-LIT MAX and ELITE-INO: - Root Canal enlargement: Prepare the root canal with apex locator function. - Apex Location: Measure the length of the root canal. - Multi-function: Measuring the length while root canal preparation. The device can save 9 programs, each program can set different parameters according to the user. ### E-LITE PRO: The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable. There is only one function features for E-LITE PRO: - Root Canal enlargement: Prepare the root canal, without apex locator function. The device can save 9 programs, each program can set different parameters according to the user. The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor is intended to be sterilized prior to use. The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.
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    K Number
    K242383
    Device Name
    Apex Locator
    Manufacturer
    Shenzhen Rogin Medical Co., Ltd.
    Date Cleared
    2025-03-07

    (207 days)

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

    Shenzhen Rogin Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
    Device Description
    Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.
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