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

    Arcad SmileStudio and Aligner System

    K Number: K192244 · Decision May 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Arcad SmileStudio and Aligner System
    K Number
    K192244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arcadlab
    Date Received
    August 19, 2019
    Decision Date
    May 11, 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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