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

    BRUIS Software Suite

    K Number: K191720 · Decision Apr 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    295

    Basic Information

    Device Name
    BRUIS Software Suite
    K Number
    K191720
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mechanodontics, Inc.
    Date Received
    June 27, 2019
    Decision Date
    April 17, 2020
    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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