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510(k) Data Aggregation
K Number
K983161Device 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
872.3810Why 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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