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

    DENTLIGHT ORAL EXAM LIGHT KIT

    K Number: K101140 · Decision Jul 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    4
    Review Days
    84

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    Basic Information

    Device Name
    DENTLIGHT ORAL EXAM LIGHT KIT
    K Number
    K101140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6350
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentlight, Inc.
    Date Received
    April 22, 2010
    Decision Date
    July 15, 2010
    Product Code
    NXV
    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
    NXV Diagnostic Light, Soft Tissue Detector

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