510(k) · Cleared
ClearedEpien Root Canal Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epien Medical, Inc. · KJJ Cleanser, Root Canal
Cleared on Feb 1, 2013 as substantially equivalent to K063703 (Ultradent Products, Inc., 2006) and 2 other predicates after a 77-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Feb 1, 2013
- Review
- 77 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003422 (2001). 8 ancestors in all, the oldest K962743 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 3 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 2 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 1 generation backK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- This deviceK123538 Epien Root Canal CleanserEpien Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −3 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −2 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −1 | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| 0 (this device) | K123538 | Epien Root Canal Cleanser | Epien Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 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 KJJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KJJ device
- #1 K241354 Sealer Solventscore 8.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K063703 | Citric Acid 20% Solution, Model 329Summary page 1…EPIEN ROOT CANAL CLEANSER Common Name Tooth Root Canal Cleanser Classification Root Canal Cleanser, Unclassified Name Predicate Devices a K063703, Ultradent Products Ultradent Citric Acid 20% Solution * K(053 167, DENTSPLY International Biopure Tm… | 2006 |
| * | K053167 | Biopure Mtad Root Canal Cleanser | 2005 |
| * | K061689 | Aquatine EC Endodontic CleanserSummary page 1…ucts Ultradent Citric Acid 20% Solution * K(053 167, DENTSPLY International Biopure Tm MTADTM Root Canal Cleanser * K06 1689, Puriore, Inc AguatineTm EC Endodontic Cleanser Device EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous… | 2006 |
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 12 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K063703.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KJJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KJJ
275in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KJJ
7in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KJJ
2in 2025
MAUDE reports naming product code KJJ, 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 | 3 | 94 | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 7 | 1 |
| 2020 | 3 | 275 | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of
tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to
enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal
systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123538: Epien Root Canal Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123538
Report an extraction error
Are you the manufacturer?
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