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

    Invisalign System

    K Number: K220287 · Decision Apr 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    11
    Review Days
    65

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    Basic Information

    Device Name
    Invisalign System
    K Number
    K220287
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Align Technology, Inc.
    Date Received
    February 1, 2022
    Decision Date
    April 7, 2022
    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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    Other Clearances by Align Technology, Inc.

    K Number Device Name
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    K232887 Invisalign Palatal Expander System
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