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

    D-CARIE, MODEL N121-M1

    K Number: K043156 · Decision Apr 28, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    D-CARIE, MODEL N121-M1
    K Number
    K043156
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neks Technologies, Inc.
    Date Received
    November 15, 2004
    Decision Date
    April 28, 2005
    Product Code
    NBL
    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
    NBL Laser, Fluorescence Caries Detection

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    Other Clearances by Neks Technologies, Inc.

    K Number Device Name
    K063321 D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138