510(k) · Cleared
Recalled · Class II · 2019Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med, Inc. · KJJ Cleanser, Root Canal
Cleared on Apr 3, 2009 as substantially equivalent to K962743 (Pulpdent Corp., 1996) and 1 other predicate after a 219-day review. Its family tree reaches back 4 generations to 2001. 6 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 3, 2009
- Review
- 219 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003422 (2001). 6 ancestors in all, the oldest K962743 (1996). 6 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 3 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 2 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 1 generation backK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- This deviceK082470 Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to…Inter-Med, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 2 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
- Descendant · cites it directly · 0 of its ownK173163 ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151852 PacEndo Sodium HyprochloritePac-Dent International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK141352 Endocyn Root Canal Irrigation SolutionOculus Innovative Sciences · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193357V-MixInter-Med/Vista Dental Products · 2020 · cites it directly1descendant
- K211813TritonInter-Med / Vista Dental · 2021 · 2 generations on0descendants
- K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. · 2018 · cites it directly0descendants
- K151852PacEndo Sodium HyprochloritePac-Dent International, Inc. · 2015 · cites it directly0descendants
- K141352Endocyn Root Canal Irrigation SolutionOculus Innovative Sciences · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −3 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −2 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −1 | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| 0 (this device) | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower… | Inter-Med, Inc. | 2009 | — |
| +1 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +2 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
| +1 | K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Ultradent Products, Inc. | 2018 | — |
| +1 | K151852 | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | 2015 | — |
| +1 | K141352 | Endocyn Root Canal Irrigation Solution | Oculus Innovative Sciences | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K962743 | Pulpdent Sodium Hypochlorite SolutionSummary page 1…function and intended use to: Equivalence * Pulpdent Sodiumr Hypochlorite Solution, manufactured by IPulpdent Corporation, K4962743 * Aquatine' TM EC I:ndodontic Cleanser; manufactured by w PuriCore, Inc.,… | 1996 |
| * | K061689 | Aquatine EC Endodontic CleanserSummary page 1…ent Sodium Hypochilit Slton, PulpdentCoprtn edic ~~~K09662743, Aquatine TM 1:C Endodontic Cleanser: PurlCore, Inc., K061689: ChlorCid Sodiuin -HypochioriteSolution, Product Code by EKS, Class 1 Exempt froin Premarket Notifi… | 2006 |
| * | — | ChlorCid Sodium Hypochlorite Solution Named without a submission number |
What descends from it? (6)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2019 | Class II | Z-0011-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0012-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0015-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0016-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0017-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0013-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
| Jun 27, 2019 | Class II | Z-0014-2020 | Process control | The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K193357 (Inter-Med/Vista Dental Products, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K962743.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM solutions used for the debridement and in the instrumentation of root canal. Sodium Hypochlorite 3% & 6% and Chlor-XTRATM 6 % are Sodium Hypochiorite solutions in water.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082470 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082470
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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