BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Ceramic Bracket

    K Number: K180952 · Decision Jun 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    422

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    Basic Information

    Device Name
    Ceramic Bracket
    K Number
    K180952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mem Dental Technology Co., Ltd.
    Date Received
    April 11, 2018
    Decision Date
    June 7, 2019
    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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    Other Clearances by Mem Dental Technology Co., Ltd.

    K Number Device Name
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