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

    KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B

    K Number: K122039 · Decision Dec 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    13
    Review Days
    169

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    Basic Information

    Device Name
    KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
    K Number
    K122039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kettenbach GmbH & Co. KG
    Date Received
    July 11, 2012
    Decision Date
    December 27, 2012
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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