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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    BIJOU Orthodontic Ceramic Bracket

    K Number: K152167 · Decision May 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    297

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    Basic Information

    Device Name
    BIJOU Orthodontic Ceramic Bracket
    K Number
    K152167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    World Bio Tech Co., Ltd.
    Date Received
    August 4, 2015
    Decision Date
    May 27, 2016
    Product Code
    NJM
    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
    NJM Bracket, Ceramic, Orthodontic

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