510(k) · Cleared
ClearedObtura Gutta Percha Delivery System, Model 823-700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Young O/S, LLC · EKR Plugger, Root Canal, Endodontic
Cleared on Dec 1, 2004 as substantially equivalent to K832654 (Unitek Corp., 1983) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it.
- Decided
- Dec 1, 2004
- Review
- 50 days
- Class
- Class I
- Product code
- EKR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832654 (1983). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K060347B&L L-Beta, Model WL-B1B&L Biotech Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832654 | Heated Gutta Percha Delivery System | Unitek Corp. | 1983 | — |
| 0 (this device) | K042828 | Obtura Gutta Percha Delivery System, Model 823-700 | Young O/S, LLC | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K832654 | Heated Gutta Percha Delivery SystemSummary page 1…d Gutta Percha System Classification Name: Instrument, Filling, Plastic, Dental Predicate Device: Heated Gufta Percha System 51 0(k) #K832654 and/or Elements Obturation Unit 51 0(k) #K031664 Descr… | 1983 |
| * | K031664 | Elements Obturation UnitSummary page 1…rcha System 51 0(k) #K832654 and/or Elements Obturation Unit 51 0(k) #K031664 Description of the Device: The device is an electulcally powered dental device used for heating gutta percha and placing the soft… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060347 | B&L L-Beta, Model WL-B1 | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060347 (B&L Biotech Co., Ltd., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EKR devicesEKR 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EKR
2in 2023
MAUDE reports naming product code EKR, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 1 | 5 |
| 2018 | 0 | — | 0 | 45 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Obtura is 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/K042828 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042828: Obtura Gutta Percha Delivery System, Model 823-700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042828
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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