510(k) · Cleared

Cleared

Fibiocore

K020431510(k) TraditionalCleared Jul 3, 2002145-day reviewClass I21 CFR 872.3810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jul 3, 2002 as substantially equivalent to K012354 (Danville Materials, Inc., 2001) and 4 other predicates after a 145-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.

Decided: Jul 3, 2002
Review: 145 days
Class: Class I
Product code: ELR
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K945370 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK945370 C-POSTBisco, Inc. · 1995
1 generation backK012354 Snowpost, SnowlightDanville Materials, Inc. · 2001
This deviceK020431 FibiocoreEst. Anthogyr · 2002
Descendant · cites it directly · 0 of its ownK060075 Fiber-Metal PostForemost Dental, LLC · 2006

Most influential descendants

Showing 1 of 1 · See all

K060075Fiber-Metal PostForemost Dental, LLC · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945370	C-POST	Bisco, Inc.	1995	—
−1	K012354	Snowpost, Snowlight	Danville Materials, Inc.	2001	—
0 (this device)	K020431	Fibiocore	Est. Anthogyr	2002	—
+1	K060075	Fiber-Metal Post	Foremost Dental, LLC	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K020431, 1995–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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

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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K012354	Snowpost, Snowlight	Danville Materials, Inc.	2001	—
*	K945370	C-POST Summary page 1 …vice - Substantial Equivalence The modified device is substantially equivalent to the previously cleared Carbotech Snowpost (KO12354), Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (KO00311 ), Jeneric/Pentron FibreKor Post (K983266), and the Harald Nordin Glassix post…	Bisco, Inc.	1995	—
*	K000311	Parapost Fiber White	Coltene/Whaledent, Inc.	2000	—
*	K983266	Fibrekor Post System Summary page 1 …the previously cleared Carbotech Snowpost (KO12354), Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (KO00311 ), Jeneric/Pentron FibreKor Post (K983266), and the Harald Nordin Glassix post (K003221) devices. The modified device is substantially equivalent in quality of m…	Jeneric/Pentron, Inc.	1998	—
*	K003221	Harald Nordin Glassix Glass Fiber Composite Dental Post Summary page 1 …2354), Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (KO00311 ), Jeneric/Pentron FibreKor Post (K983266), and the Harald Nordin Glassix post (K003221) devices. The modified device is substantially equivalent in quality of mechanical characteristics, of mechanical safet…	Harald Nordin S.A	2000	—

Also cleared against K012354: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060075	Fiber-Metal Post	Foremost Dental, LLC	2006	0

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?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K060075 (Foremost Dental, LLC, 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K012354.

How does its category compare?

All ELR devices

ELR 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

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ELR

1in 2025

2007high 30 (2014) · low 0 (2023)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	8
2008	—	0	5
2009	—	1	3
2010	—	0	1
2011	—	0	4
2012	—	0	13
2013	—	0	6
2014	—	0	30
2015	—	0	3
2016	—	0	8
2017	—	0	1
2018	—	1	5
2019	—	0	20
2020	—	0	2
2021	—	0	3
2022	—	0	2
2023	—	0	0
2024	—	0	1
2025	—	0	1
2026	—	0	—

What is it indicated for?

The FlBlOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020431 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020431: Fibiocore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020431

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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