BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    Dental Handpiece, Wireless Endodontic Handpiece, endoit

    K Number: K232810 · Decision Nov 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    58

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    Basic Information

    Device Name
    Dental Handpiece, Wireless Endodontic Handpiece, endoit
    K Number
    K232810
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro-Nx Co., Ltd.
    Date Received
    September 12, 2023
    Decision Date
    November 9, 2023
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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