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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CURA-Temp

    K Number: K202965 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    2
    Review Days
    812

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    Basic Information

    Device Name
    CURA-Temp
    K Number
    K202965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mgnewton , Ltd.
    Date Received
    September 30, 2020
    Decision Date
    December 21, 2022
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Mgnewton , Ltd.

    K Number Device Name
    K202963 ELEC Master, ELEC Master Dual