510(k) · Cleared
ClearedCitric Acid 20% Solution, Model 329
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · KJJ Cleanser, Root Canal
Cleared on Dec 21, 2006 as substantially equivalent to K032627 (Ultradent Products, Inc., 2003) after an 8-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Dec 21, 2006
- Review
- 8 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032627 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032627 Ultradent Citric Acid 10% SolutionUltradent Products, Inc. · 2003
- This deviceK063703 Citric Acid 20% Solution, Model 329Ultradent Products, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK241354 Sealer SolventInter-Med, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK123538 Epien Root Canal CleanserEpien Medical, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032627 | Ultradent Citric Acid 10% Solution | Ultradent Products, Inc. | 2003 | — |
| 0 (this device) | K063703 | Citric Acid 20% Solution, Model 329 | Ultradent Products, Inc. | 2006 | — |
| +1 | K241354 | Sealer Solvent | Inter-Med, Inc. | 2024 | — |
| +1 | K123538 | Epien Root Canal Cleanser | Epien Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K032627 | Ultradent Citric Acid 10% SolutionSummary page 1…fication Product Code: KJJ Legally Marketed Predicate Devices to Which Equivalence is Claimed: Predicate: Citric Acid 10% Solution, Ultradent Products, Inc. (K032627). Manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, UT 84095. Product Description… | 2003 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K241354 (Inter-Med, Inc., 2024) has gone furthest, with 0 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?
Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063703 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063703: Citric Acid 20% Solution, Model 329.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063703
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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