510(k) · Cleared

Recalled · Class II · 2017

Elements Obturation Unit

K031664510(k) TraditionalCleared Apr 28, 2004335-day reviewClass I21 CFR 872.4565Recalls 3

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

Sybron Endo/Analytic · EKR Plugger, Root Canal, Endodontic

Cleared on Apr 28, 2004 after a 335-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 3 times.

Decided: Apr 28, 2004
Review: 335 days
Class: Class I
Product code: EKR
Recalls: 3
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK031664 Elements Obturation UnitSybron Endo/Analytic · 2004
Descendant · cites it directly · 1 of its ownK042828 Obtura Gutta Percha Delivery System, Model 823-700Young O/S, LLC · 2004
Descendant · 2 generations on · 0 of its ownK060347 B&L L-Beta, Model WL-B1B&L Biotech Co., Ltd. · 2006

Most influential descendants

Showing 2 of 2 · See all

K042828Obtura Gutta Percha Delivery System, Model 823-700Young O/S, LLC · 2004 · cites it directly1descendant
K060347B&L L-Beta, Model WL-B1B&L Biotech Co., Ltd. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K031664	Elements Obturation Unit	Sybron Endo/Analytic	2004	—
+1	K042828	Obtura Gutta Percha Delivery System, Model 823-700	Young O/S, LLC	2004	—
+2	K060347	B&L L-Beta, Model WL-B1	B&L Biotech Co., Ltd.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0

FIG. 1 — Lineage of K031664, 2004–2006Source: 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? (2)

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
*	—	System B HeatSource Named without a submission number			—
*	—	Obtura II Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K042828	Obtura Gutta Percha Delivery System, Model 823-700	Young O/S, LLC	2004	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 27, 2017	Class II	Z-0413-2018	Under Investigation by firm	Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
Jan 17, 2013	Class II	Z-1544-2013	Labeling mix-ups	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
Jan 17, 2013	Class II	Z-1545-2013	Labeling mix-ups	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K042828 (Young O/S, LLC, 2004) has gone furthest, with 1 descendant of its own.

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?

The Elements Obturation Unit is intended to be used in Dentistry to:

1. Provide continuous heat at the tip of a dental instrument to test tooth response to

thermal stimulus,

2. For tissue cauterization and coagulation, and

3. To backfill and downpack gutta percha during Endodontic root canal treatment.

4. When in Extruder mode, the Elements Obturation Unit is used only to backfill

gutta percha during root canal obturation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031664 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031664: Elements Obturation Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031664

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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