BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Dental Low-speed Turbine Handpiece

    K Number: K170236 · Decision Nov 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    4
    Review Days
    300

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    Basic Information

    Device Name
    Dental Low-speed Turbine Handpiece
    K Number
    K170236
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Jinme Medical Technology Co., Ltd.
    Date Received
    January 25, 2017
    Decision Date
    November 21, 2017
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Guangdong Jinme Medical Technology Co., Ltd.

    K Number Device Name
    K240337 Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
    K240340 Surgical Drive System (Model: ES70, ES90, E8)
    K170229 Dental High-speed Turbine Handpiece