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510(k) Data Aggregation

    K Number
    K142063
    Device Name
    #8C RENEGADE DENTAL HANDPIECE
    Date Cleared
    2014-10-28

    (90 days)

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

    HANDPIECE CLUB, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The #8C Renegade Dental Handpiece is intended for use in general dentistry by licensed professionals for removing carious material, reducing hard tooth surfaces, cavity preparations, restorations, restorations and polishing teeth.
    Device Description
    The #8C Renegade is a high speed air turbine handpiece with a push-button autochuck. The handpiece is powered by compressed air (26-35 psi) which activates an air turbine causing rotation of the chuck holding a burr (not supplied with the handpiece) at 380,000-530,000 rpm. The handpiece handle and head are constructed of chrome plated brass. The handpiece features a four (4) hole connector for air and water input and return. The head and burr are cooled by a water/air mist. The handpiece is supplied non-sterile and must be cleaned, lubricated and sterilized prior to each patient use.
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