BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MODIFICATION TO: VELSCOPE

    K Number: K070523 · Decision Apr 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    41

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    Basic Information

    Device Name
    MODIFICATION TO: VELSCOPE
    K Number
    K070523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6350
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Led Dental, Inc.
    Date Received
    February 23, 2007
    Decision Date
    April 5, 2007
    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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