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

    ORTHODONTIC FLOWABLE BRACKET ADHESIVE

    K Number: K120619 · Decision May 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    192
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    ORTHODONTIC FLOWABLE BRACKET ADHESIVE
    K Number
    K120619
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3750
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novocol, Inc.
    Date Received
    February 29, 2012
    Decision Date
    May 21, 2012
    Product Code
    DYH
    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
    DYH Adhesive, Bracket And Tooth Conditioner, Resin

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