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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    Dental High-speed Handpiece and Accessories

    K Number: K173943 · Decision Jul 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    Dental High-speed Handpiece and Accessories
    K Number
    K173943
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microp Technology (Taiwan), Inc.
    Date Received
    December 26, 2017
    Decision Date
    July 24, 2018
    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 Microp Technology (Taiwan), Inc.

    K Number Device Name
    K202786 Dental Low-speed Handpieces and Accessories