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510(k) Data Aggregation

    K Number
    K983161
    Device Name
    KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
    Manufacturer
    Date Cleared
    1998-09-30

    (21 days)

    Product Code
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    SABRE-K LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The K4 products fall into the general category of prefabricated (preformed) posts which comprises threaded and non-threaded versions. The K4 system is designed is designed so that the posts are cemented into canals tapped previously with a thread. This means that the K4 system is pre-threaded and therefore placement is passive (not active) as the posts themselves are not cutting into the dentine at the cementation stage. If placed in accordance with the instructions the process will largely eliminate fitting stress. Posts are placed to support a core so that a crown can complete a tooth restoration, or to stop the coronal tooth substance from shearing off. The introduction of titanium versions of certain of the K4 products does not change the method or the purpose of the placement. The dentist is simply to be offered a choice of post material. We will not seek to influence the dentist's decision.
    Device Description
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