# K983161: Kurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- the Ready Core Kit, Kurer Fin-Loc

- Pathway: 510(k) (Traditional)
- Applicant: Sabre-K, Ltd.
- Decided: Sep 30, 1998 after 21 days
- Product code: ELR (Post, Root Canal)
- Device class: 1
- Regulation: 21 CFR 872.3810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 sheaning 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.

Source page: https://510kreport.com/device/K983161
Methodology: https://510kreport.com/methodology