BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RODIN Palette Naturalizing Kit

    K Number: K223365 · Decision Mar 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    51
    Applicant Total
    11
    Review Days
    144

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    Basic Information

    Device Name
    RODIN Palette Naturalizing Kit
    K Number
    K223365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3310
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Belport Company, Inc., Gingi-Pak
    Date Received
    November 3, 2022
    Decision Date
    March 27, 2023
    Product Code
    EBD
    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
    EBD Coating, Filling Material, Resin

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