510(k) · Cleared
ClearedOxy-Glide Root Canal Cleanser & Lub.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Super Glide, Inc. · KJJ Cleanser, Root Canal
Cleared on Nov 19, 1999 after an 81-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Nov 19, 1999
- Review
- 81 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK992919 Oxy-Glide Root Canal Cleanser & Lub.Super Glide, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK082470 Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to…Inter-Med, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK070401 Endo-CHXEssential Dental Systems, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 2 generations on · 1 of its ownK112250 CHX=CHX PlusInter-Med, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K061689Aquatine EC Endodontic CleanserPuricore, Inc. · 2006 · cites it directly11descendants
- K082470Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…Inter-Med, Inc. · 2009 · 2 generations on6descendants
- K070401Endo-CHXEssential Dental Systems, Inc. · 2007 · 2 generations on2descendants
- K193357V-MixInter-Med/Vista Dental Products · 2020 · 3 generations on1descendant
- K112250CHX=CHX PlusInter-Med, Inc. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992919 | Oxy-Glide Root Canal Cleanser & Lub. | Super Glide, Inc. | 1999 | — |
| +1 | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| +2 | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower… | Inter-Med, Inc. | 2009 | 7 |
| +2 | K070401 | Endo-CHX | Essential Dental Systems, Inc. | 2007 | — |
| +3 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +2 | K112250 | CHX=CHX Plus | Inter-Med, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | — | RC-Prep Named without a submission number |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061689 | Aquatine EC Endodontic Cleanser | 2006 | 11 |
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, K061689 (Puricore, Inc., 2006) has gone furthest, with 11 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 | — |
What is it indicated for?
Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992919: Oxy-Glide Root Canal Cleanser & Lub..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992919
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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