510(k) · Cleared
ClearedCleanser Root Canal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerkamed Wojciech Pawlowski · KJJ Cleanser, Root Canal
Cleared on Oct 3, 2013 as substantially equivalent to K082470 (Inter-Med, Inc., 2009) and 1 other predicate after a 251-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Oct 3, 2013
- Review
- 251 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003422 (2001). 7 ancestors in all, the oldest K962743 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 4 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 3 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 2 generations backK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- 1 generation backK082470 Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to…Inter-Med, Inc. · 2009 · Recalled
- This deviceK130180 Cleanser Root CanalCerkamed Wojciech Pawlowski · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −4 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −3 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −2 | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| −1 | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower… | Inter-Med, Inc. | 2009 | 7 |
| 0 (this device) | K130180 | Cleanser Root Canal | Cerkamed Wojciech Pawlowski | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…Summary page 1…ified (pre-amendment) Classification Product Code KJJ Predicate devices Sodium Hypochlorite 3% &6%; Inter Med Inc/Vista Dental, K(082470 Pulpdlent Sodium Hypochlorite Solution, K(962743. Descritpion… | 2009 |
| * | K962743 | Pulpdent Sodium Hypochlorite SolutionSummary page 1…Sodium Hypochlorite 3% &6%; Inter Med Inc/Vista Dental, K(082470 Pulpdlent Sodium Hypochlorite Solution, K(962743. Descritpion Liquid for root canals rinsing Active ingredient Sodium Hypo… | 1996 |
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 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 4 other devices also cite its predicate K082470.
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?
Liquid used for root canal rinsing during endodontic treatment.
During mechanical canal widening it removes the non-vital pulp debris.
It cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130180 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130180: Cleanser Root Canal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130180
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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