BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SmileAlign Orthodontic Aligner System

    K Number: K191774 · Decision Sep 30, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    SmileAlign Orthodontic Aligner System
    K Number
    K191774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Global Biotech, Inc.
    Date Received
    July 2, 2019
    Decision Date
    September 30, 2019
    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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