510(k) · Cleared
ClearedKurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- the Ready Core Kit, Kurer Fin-Loc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sabre-K, Ltd. · ELR Post, Root Canal
Cleared on Sep 30, 1998 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 30, 1998
- Review
- 21 days
- Class
- Class I
- Product code
- ELR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All ELR devicesELR Post, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELR
FDA has decided no ELR device since 2007.
Median 510(k) review, days · ELR
Too few ELR 510(k)s in any year since 2007 to give a median.
Recalls per year · ELR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELR
1in 2025
MAUDE reports naming product code ELR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 5 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983161: Kurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- the Ready Core Kit, Kurer Fin-Loc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983161
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026