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

    LumiCare Caries Diagnostic Rinse

    K Number: K200601 · Decision Mar 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    385

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    Basic Information

    Device Name
    LumiCare Caries Diagnostic Rinse
    K Number
    K200601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1740
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GreenMark Biomedical, Inc.
    Date Received
    March 9, 2020
    Decision Date
    March 29, 2021
    Product Code
    LFC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFC Device, Caries Detection

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