510(k) · Cleared
ClearedFibrekor Post System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · ELR Post, Root Canal
Cleared on Nov 9, 1998 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Nov 9, 1998
- Review
- 53 days
- Class
- Class I
- Product code
- ELR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK983266 Fibrekor Post SystemJeneric/Pentron, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK012354 Snowpost, SnowlightDanville Materials, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK020431 FibiocoreEst. Anthogyr · 2002
- Descendant · 2 generations on · 0 of its ownK060075 Fiber-Metal PostForemost Dental, LLC · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983266 | Fibrekor Post System | Jeneric/Pentron, Inc. | 1998 | — |
| +1 | K012354 | Snowpost, Snowlight | Danville Materials, Inc. | 2001 | — |
| +1 | K020431 | Fibiocore | Est. Anthogyr | 2002 | — |
| +2 | K060075 | Fiber-Metal Post | Foremost Dental, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K012354 (Danville Materials, Inc., 2001) has gone furthest, with 2 descendants of its own.
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?
Reinforcement of an endodontically involved tooth
Retention of Core and or Core Material
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/K983266 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983266: Fibrekor Post System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026