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

    ELEC Master, ELEC Master Dual

    K Number: K202963 · Decision May 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    2
    Review Days
    947

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    Basic Information

    Device Name
    ELEC Master, ELEC Master Dual
    K Number
    K202963
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mgnewton , Ltd.
    Date Received
    September 30, 2020
    Decision Date
    May 5, 2023
    Product Code
    EIA
    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
    EIA Unit, Operative Dental

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    Other Clearances by Mgnewton , Ltd.

    K Number Device Name
    K202965 CURA-Temp