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

    LUXEN 5G

    K Number: K241151 · Decision Sep 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    3
    Review Days
    158

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    Basic Information

    Device Name
    LUXEN 5G
    K Number
    K241151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalmax Co., Ltd.
    Date Received
    April 25, 2024
    Decision Date
    September 30, 2024
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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    Other Clearances by Dentalmax Co., Ltd.

    K Number Device Name
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