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510(k) Data Aggregation

    K Number
    K180845
    Device Name
    Maxima Electric System
    Manufacturer
    Handpiece Headquarters - HPR Inc.
    Date Cleared
    2019-07-25

    (479 days)

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

    Handpiece Headquarters - HPR Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maxima Electric System 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. This system is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm. Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program. The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces. The control box is power by a power supply AC/DC voltage 36 VDC. Maxima Electric System consists of the following components: 1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord A control unit, Motor Cable and a Micro-motor.
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