510(k) · Cleared
ClearedCleaniCal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maruchi · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Feb 12, 2021 as substantially equivalent to K060365 (Ivoclar Vivadent, Inc., 2006) and 1 other predicate after a 227-day review. Its family tree reaches back 8 generations to 1999. 2 later devices descend from it.
- Decided
- Feb 12, 2021
- Review
- 227 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K990131 (1999). 41 ancestors in all, the oldest K820215 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 7 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 6 generations backK032268 MBCPBiomatlante · 2003
- 5 generations backK043005 Modification to MBCPBiomatlante · 2005
- 4 generations backK051885 MBCPBiomatlante · 2005
- 3 generations backK060732 MBCP GelBiomatlante · 2006
- 2 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 1 generation backK170175 Endoseal MtaMaruchi · 2018
- This deviceK201799 CleaniCalMaruchi · 2021
- Descendant · cites it directly · 0 of its ownK212475 Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited · 2022
- Descendant · cites it directly · 0 of its ownK211905 UltraCal XSUltradent Products, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −8 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −7 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −6 | K032268 | MBCP | Biomatlante | 2003 | — |
| −5 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −4 | K051885 | MBCP | Biomatlante | 2005 | — |
| −3 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −1 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| 0 (this device) | K201799 | CleaniCal | Maruchi | 2021 | — |
| +1 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | 2022 | — |
| +1 | K211905 | UltraCal XS | Ultradent Products, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 EJK? 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 EJK device
- #1 K261728 One-Fil LCscore 12.3 · 3 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 |
|---|---|---|---|
| * | K060365 | ApexcalSummary page 4…droxide ·Regulation Number 872.3250 ·Class: 2 ·Classification Product Code: EJK ·Subsequent Product Code: KIF 3. Predicate Device K060365, APEXCAL, Ivoclar Vivadent K170175, ENDOSEAL MTA, MARUCHI 4. DEVICE DESCRIPTION CleaniCal is a type of pre-fill… | 2006 |
| * | K170175 | Endoseal MtaSummary page 4…·Class: 2 ·Classification Product Code: EJK ·Subsequent Product Code: KIF 3. Predicate Device K060365, APEXCAL, Ivoclar Vivadent K170175, ENDOSEAL MTA, MARUCHI 4. DEVICE DESCRIPTION CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with… | 2018 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 41 ancestors has a recall of any class.
- Of its descendants, K212475 (Prevest Denpro Limited, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060365.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EJK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · EJK
260in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EJK
No recall names EJK since 2007.
Adverse event reports per year · EJK
1in 2022
MAUDE reports naming product code EJK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 93 | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 260 | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including:
* Temporary disinfectant dressings in the obturation of root canals;
* Indirect pulp capping or management of deep caries lesions; or
* Direct pulp capping.
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/K201799 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201799: CleaniCal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201799
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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