510(k) · Cleared
ClearedEdta Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essential Dental Systems, Inc. · KJJ Cleanser, Root Canal
Cleared on Dec 13, 2007 as substantially equivalent to K024198 (Sybron Dental Specialties, Inc., 2003) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Dec 13, 2007
- Review
- 94 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950365 (1995). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK950365 Moyco-EdtaUnion Broach, Div. Moyco Industries, Inc. · 1995
- This deviceK072555 Edta PlusEssential Dental Systems, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK153528 PacEndo EDTAPac-Dent International, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- Descendant · 3 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 4 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Most influential descendants
Showing 4 of 4 · See all- K153528PacEndo EDTAPac-Dent International, Inc. · 2016 · cites it directly3descendants
- K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020 · 2 generations on2descendants
- K193357V-MixInter-Med/Vista Dental Products · 2020 · 3 generations on1descendant
- K211813TritonInter-Med / Vista Dental · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950365 | Moyco-Edta | Union Broach, Div. Moyco Industries, Inc. | 1995 | — |
| 0 (this device) | K072555 | Edta Plus | Essential Dental Systems, Inc. | 2007 | — |
| +1 | K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016 | — |
| +2 | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +3 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +4 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K024198 | SmearclearSummary page 1…Prepared: September 6, 2007 Contact: Mr. Brian Rasimick 2. Name of the Device: EDTA Plus 3. Predicate Device Information: 1. SmearClear®), K# 024198, Sybror Dental Specialties, Inc., Orange, CA 2. Moyco-EDTA, K#950365, Union Broach, Div. Moyco Industries, Inc. Emig… | 2003 |
| * | K950365 | Moyco-EdtaSummary page 1…f the Device: EDTA Plus 3. Predicate Device Information: 1. SmearClear®), K# 024198, Sybror Dental Specialties, Inc., Orange, CA 2. Moyco-EDTA, K#950365, Union Broach, Div. Moyco Industries, Inc. Emigsville, PA 4. Device Description: EDTA Plus is a root canal cleans… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153528 | PacEndo EDTA | 2016 | 3 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K153528 (Pac-Dent International, Inc., 2016) has gone furthest, with 3 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. 2007, 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?
EDTA Plus is a root canal cleanser designed 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/K072555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072555: Edta Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072555
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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