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

    Braces on Demand Bracket

    K Number: K201940 · Decision Dec 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    143

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    Basic Information

    Device Name
    Braces on Demand Bracket
    K Number
    K201940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braces on Demand, Inc.
    Date Received
    July 13, 2020
    Decision Date
    December 3, 2020
    Product Code
    DYW
    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
    DYW Bracket, Plastic, Orthodontic

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