510(k) · Cleared
ClearedPacEndo EDTA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pac-Dent International, Inc. · KJJ Cleanser, Root Canal
Cleared on Feb 1, 2016 as substantially equivalent to K072555 (Essential Dental Systems, Inc., 2007) after a 54-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Feb 1, 2016
- Review
- 54 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950365 (1995). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950365 Moyco-EdtaUnion Broach, Div. Moyco Industries, Inc. · 1995
- 1 generation backK072555 Edta PlusEssential Dental Systems, Inc. · 2007
- This deviceK153528 PacEndo EDTAPac-Dent International, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- Descendant · 2 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 3 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950365 | Moyco-Edta | Union Broach, Div. Moyco Industries, Inc. | 1995 | — |
| −1 | K072555 | Edta Plus | Essential Dental Systems, Inc. | 2007 | — |
| 0 (this device) | K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016 | — |
| +1 | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +2 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +3 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 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? (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 | Decided |
|---|---|---|---|
| * | K072555 | Edta PlusSummary page 4…mmon Name: Endodontic Cleanser Device Classification: Unclassified Classification Product Code: KJJ Classification Name: Cleanser, Root Canal Predicate Device EDTA Plus (K072555) Description of Device TM PacEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. Th… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193409 | Vista Rinse, Vista Rinse Plus | 2020 | 2 |
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 21 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193409 (Inter-Med/Vista Dental Products, 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
PacEndo EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153528: PacEndo EDTA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153528
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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