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

    Alpha Pure

    K Number: K163117 · Decision May 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    183

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    Basic Information

    Device Name
    Alpha Pure
    K Number
    K163117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Koroad America
    Date Received
    November 7, 2016
    Decision Date
    May 9, 2017
    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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