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

    Impla-NX (Model: ISE-270M)

    K Number: K201192 · Decision May 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    382

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    Basic Information

    Device Name
    Impla-NX (Model: ISE-270M)
    K Number
    K201192
    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
    May 4, 2020
    Decision Date
    May 21, 2021
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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