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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K042759
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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).

    AI/ML Overview

    This document pertains to the 510(k) premarket notification for the "ELEC-LED" dental handpiece control unit. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness or performance in an AI-assisted diagnostic context.

    Therefore, none of the requested information regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment can be found in this document.

    The document details the device's technical specifications, indications for use, and a comparison to a predicate device ("Optima MX INT"). It also lists performance tests conducted, which are primarily non-clinical bench tests for electrical safety, mechanical standards, and biocompatibility, as well as software documentation following FDA guidance for medical device software.

    The performance tests mentioned are as follows:

    • ISO 3964:2016 Dental Handpieces Coupling dimensions
    • ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
    • ISO 14457:2017 Dentistry Handpieces and motors
    • IEC 60601-1, IEC 62366-1, IEC 60601-1-2: Electrical safety and EMC
    • IEC80601-2-60:2012: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
    • IEC 62366: Application of usability engineering to medical devices
    • ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation

    These tests are standard for dental equipment to ensure safety and function, but they are not clinical studies designed to assess diagnostic accuracy or the impact of AI on human reader performance.

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