510(k) · Cleared

Cleared

Fiber-Metal Post

K060075510(k) TraditionalCleared Mar 30, 200679-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

Foremost Dental, LLC · ELR Post, Root Canal

Cleared on Mar 30, 2006 as substantially equivalent to K012354 (Danville Materials, Inc., 2001) and 2 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1995.

Decided: Mar 30, 2006
Review: 79 days
Class: Class I
Product code: ELR
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K945370 (1995). 10 ancestors in all, the oldest K913040 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK945370 C-POSTBisco, Inc. · 1995
2 generations backK012354 Snowpost, SnowlightDanville Materials, Inc. · 2001
1 generation backK020431 FibiocoreEst. Anthogyr · 2002
This deviceK060075 Fiber-Metal PostForemost Dental, LLC · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K945370	C-POST	Bisco, Inc.	1995	—
−2	K012354	Snowpost, Snowlight	Danville Materials, Inc.	2001	—
−1	K020431	Fibiocore	Est. Anthogyr	2002	—
0 (this device)	K060075	Fiber-Metal Post	Foremost Dental, LLC	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1998	1	0
2000	2	0
2001	2	0
2003	1	0

FIG. 1 — Lineage of K060075, 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? (3)

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 Summary page 1 …to several currently marketed root canal posts: Product Name 51 0(k) 510(k) Sponsor Snowpost IK01 2354 Danville Materials, Inc. everStick TM Post K030820 Stick Tech, Ltd. Fibiocore…	Danville Materials, Inc.	2001	—
*	K030820	Everstick Post Summary page 1 …51 0(k) 510(k) Sponsor Snowpost IK01 2354 Danville Materials, Inc. everStick TM Post K030820 Stick Tech, Ltd. Fibiocore K020431 Anthogyr Indications for Use: The Fiber-Metal Po…	Stick Tech, Ltd.	2003	—
*	K020431	Fibiocore Summary page 1 …IK01 2354 Danville Materials, Inc. everStick TM Post K030820 Stick Tech, Ltd. Fibiocore K020431 Anthogyr Indications for Use: The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the…	Est. Anthogyr	2002	—

Also cleared against K012354: 1 other device →

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.

What does this lineage say?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
None of the 10 ancestors has a recall.
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 Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060075 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060075: Fiber-Metal Post.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060075

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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