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    K Number
    K251701

    Validate with FDA (Live)

    Device Name
    Star E900 Electric System
    Manufacturer
    Dentalez, Inc., Stardental Division
    Date Cleared
    2026-01-12

    (224 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K240183,K163402
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K240183

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Star E900 Electric System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

    Device Description

    The Star E900 Electric System is comprised of a power supply, control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100-40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.

    The system has two different operating modes, preparation mode for dental restorations and prophylaxis procedures and endodontic mode for endodontic procedures. Within each mode there are 10 different profile settings that can be customized by the user. Each profile can be customized for the gear ratio, speed, direction of rotation, light and for the endodontic mode, the torque can also be customized.

    The motor incorporates RFID (radio frequency identification) technology. This passive RFID tag does not have a built-in energy source. The RFID tag allows the practitioner to track the device within the office only if the practitioner has a separate reader. The RFID reader allows the practitioner to track such things as usage and maintenance.

    The control unit is programmed to detect a rise in the temperature of the handpiece, if the handpiece is equipped with a thermal sensor, in order to reduce the risk of patient injury. It will also detect if there is an overcurrent condition in the motor which could cause damage to the system.

    The Star E900 Electric System is available in two different models. One model is a tabletop stand-alone unit and the other model can be integrated into a dental delivery unit.

    The Star E900 Electric System uses a cellular connection to connect with the cloud. Through this connection, the system transmits data concerning the operation of the system. There is no patient information transmitted or stored on the cloud. The system cannot be operated through the cellular connection. System updates are transmitted as needed through this connection. The user has the option of accessing a web application that will allow the user to see the functions of the system.

    AI/ML Overview

    N/A

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