BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    SEE-IT CARIES DETECTOR

    K Number: K060330 · Decision Apr 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    SEE-IT CARIES DETECTOR
    K Number
    K060330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1740
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ronvig Dental Mfg. A/S
    Date Received
    February 9, 2006
    Decision Date
    April 7, 2006
    Product Code
    LFC
    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
    LFC Device, Caries Detection

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