510(k) · Cleared
ClearedMoyco-Edta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Union Broach, Div. Moyco Industries, Inc. · KJJ Cleanser, Root Canal
Cleared on Apr 27, 1995 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 27, 1995
- Review
- 86 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK950365 Moyco-EdtaUnion Broach, Div. Moyco Industries, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK072555 Edta PlusEssential Dental Systems, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK153528 PacEndo EDTAPac-Dent International, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- Descendant · 4 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 5 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072555Edta PlusEssential Dental Systems, Inc. · 2007 · cites it directly4descendants
- K153528PacEndo EDTAPac-Dent International, Inc. · 2016 · 2 generations on3descendants
- K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020 · 3 generations on2descendants
- K193357V-MixInter-Med/Vista Dental Products · 2020 · 4 generations on1descendant
- K211813TritonInter-Med / Vista Dental · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950365 | Moyco-Edta | Union Broach, Div. Moyco Industries, Inc. | 1995 | — |
| +1 | K072555 | Edta Plus | Essential Dental Systems, Inc. | 2007 | — |
| +2 | K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016 | — |
| +3 | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +4 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +5 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072555 (Essential Dental Systems, Inc., 2007) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K950365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950365: Moyco-Edta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950365
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026