BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DCI Edge Dental Chair with Operative Unit

    K Number: K151987 · Decision Jun 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    62
    Applicant Total
    1
    Review Days
    320

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    Basic Information

    Device Name
    DCI Edge Dental Chair with Operative Unit
    K Number
    K151987
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dci
    Date Received
    July 17, 2015
    Decision Date
    June 1, 2016
    Product Code
    KLC
    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
    KLC Chair, Dental, With Operative Unit

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