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510(k) Data Aggregation

    K Number
    K050612

    Validate with FDA (Live)

    Device Name
    LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
    Manufacturer
    LIGHTSPEED TECHNOLOGY, INC.
    Date Cleared
    2005-05-04

    (55 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is for use only by a licensed dentist for the purpose of delivering rotary root canal preparation treatment only. Device may also be used by licensed dental hygienist for polishing outside of teeth after cleaning.

    Device Description

    LightSpeed Cordless Endodontic Handpiece

    AI/ML Overview

    This document is a 510(k) clearance letter for the LightSpeed Cordless Endodontic Handpiece. It does not contain information about acceptance criteria or a study proving the device meets them. The letter confirms substantial equivalence to predicate devices and outlines regulatory responsibilities.

    Therefore, I cannot answer your request based on the provided text.

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