BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X

    K Number: K143104 · Decision Mar 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    13
    Review Days
    147

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    Basic Information

    Device Name
    Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
    K Number
    K143104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kettenbach GmbH & Co. KG
    Date Received
    October 29, 2014
    Decision Date
    March 25, 2015
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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