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

    Visalys CemCore, Visalys Cem Core Try In Paste

    K Number: K191527 · Decision Nov 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    13
    Review Days
    151

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    Basic Information

    Device Name
    Visalys CemCore, Visalys Cem Core Try In Paste
    K Number
    K191527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kettenbach GmbH & Co. KG
    Date Received
    June 10, 2019
    Decision Date
    November 8, 2019
    Product Code
    EMA
    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
    EMA Cement, Dental

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