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

    iSMILE

    K Number: K200908 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    2
    Review Days
    260

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    Basic Information

    Device Name
    iSMILE
    K Number
    K200908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Diagnostix, Inc.
    Date Received
    April 6, 2020
    Decision Date
    December 22, 2020
    Product Code
    NXC
    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
    NXC Aligner, Sequential

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