510(k) · Cleared

Cleared

B&L L-Beta, Model WL-B1

K060347510(k) TraditionalCleared Jun 5, 2006115-day reviewClass I21 CFR 872.4565

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

B&L Biotech Co., Ltd. · EKR Plugger, Root Canal, Endodontic

Cleared on Jun 5, 2006 as substantially equivalent to K042828 (Young O/S, LLC, 2004) after a 115-day review. Its family tree reaches back 2 generations to 1983.

Decided: Jun 5, 2006
Review: 115 days
Class: Class I
Product code: EKR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K832654 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK832654 Heated Gutta Percha Delivery SystemUnitek Corp. · 1983
1 generation backK042828 Obtura Gutta Percha Delivery System, Model 823-700Young O/S, LLC · 2004
This deviceK060347 B&L L-Beta, Model WL-B1B&L Biotech Co., Ltd. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K832654	Heated Gutta Percha Delivery System	Unitek Corp.	1983	—
−1	K042828	Obtura Gutta Percha Delivery System, Model 823-700	Young O/S, LLC	2004	—
0 (this device)	K060347	B&L L-Beta, Model WL-B1	B&L Biotech Co., Ltd.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K060347, 1983–2006Source: 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 EKR? 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? (1)

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
*	K042828	Obtura Gutta Percha Delivery System, Model 823-700 Summary page 1 …t, Product code EKR Comnmon/Usual Name: Ileated Gutta Perelha Systemn 2. Equivalent legally marketed devices: Youn~g OS LLC Obtura Hleated Gutla Perehia System, K042828 3. Indications for Use (intended use) Intended for use by professionally qualified Licensed dentists, endodonti sts and cilin…	Young O/S, LLC	2004	—

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 23 years and passes through 3 companies; a new generation was cleared every 21.2 years on median.
1 of the 3 ancestors has a recall of any class.

How does its category compare?

All EKR devices

EKR Plugger, Root Canal, Endodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKR

FDA has decided no EKR device since 2007.

Median 510(k) review, days · EKR

Too few EKR 510(k)s in any year since 2007 to give a median.

Recalls per year · EKR

1in 2017

2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · EKR

2in 2023

2007high 45 (2018) · low 0 (2007)2025

MAUDE reports naming product code EKR, 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	0
2008	—	0	0
2009	—	0	1
2010	—	0	1
2011	—	0	1
2012	—	0	0
2013	—	0	3
2014	—	0	0
2015	—	0	3
2016	—	0	5
2017	—	1	5
2018	—	0	45
2019	—	0	1
2020	—	0	1
2021	—	0	0
2022	—	0	3
2023	—	0	2
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060347: B&L L-Beta, Model WL-B1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060347

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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