BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇫🇷 France

    DentalMonitoring

    K Number: DEN230035 · Decision May 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    379

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    Basic Information

    Device Name
    DentalMonitoring
    K Number
    DEN230035
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    872.1770
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Dental Monitoring Sas
    Date Received
    May 4, 2023
    Decision Date
    May 17, 2024
    Product Code
    SBC
    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
    SBC Dental Image Analyzer