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510(k) Data Aggregation

    K Number
    K050612
    Device Name
    LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
    Manufacturer
    LIGHTSPEED TECHNOLOGY, INC.
    Date Cleared
    2005-05-04

    (55 days)

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

    LIGHTSPEED TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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