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

    DENU Composite Resin, DENU Flow Resin

    K Number: K213339 · Decision Sep 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    913
    Applicant Total
    2
    Review Days
    351

    Basic Information

    Device Name
    DENU Composite Resin, DENU Flow Resin
    K Number
    K213339
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HDI, Inc.
    Date Received
    October 7, 2021
    Decision Date
    September 23, 2022
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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