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

    Dental Handpiece, Model CA160, CA160L, and CA500L

    K Number: K220577 · Decision Jul 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    151

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    Basic Information

    Device Name
    Dental Handpiece, Model CA160, CA160L, and CA500L
    K Number
    K220577
    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
    February 28, 2022
    Decision Date
    July 29, 2022
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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