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

    iTero Element 5D

    K Number: K193659 · Decision Mar 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    11
    Review Days
    81

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    Basic Information

    Device Name
    iTero Element 5D
    K Number
    K193659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Align Technology, Inc.
    Date Received
    December 30, 2019
    Decision Date
    March 20, 2020
    Product Code
    NTK
    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
    NTK Caries Detector, Laser Light, Transmission

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