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

    Inbrace Orthodontic System

    K Number: K203442 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    Inbrace Orthodontic System
    K Number
    K203442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Swift Health Systems, Inc.
    Date Received
    November 23, 2020
    Decision Date
    February 19, 2021
    Product Code
    PNN
    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
    PNN Orthodontic Software

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