510(k) · Cleared
ClearedPrevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prevest Denpro Limited · EJK Liner, Cavity, Calcium Hydroxide
Cleared on May 13, 2022 as substantially equivalent to K201799 (Maruchi, 2021) and 2 other predicates after a 280-day review. Its family tree reaches back 9 generations to 1999.
- Decided
- May 13, 2022
- Review
- 280 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K990131 (1999). 45 ancestors in all, the oldest K820215 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations between
- 3 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 2 generations backK170175 Endoseal MtaMaruchi · 2018
- 1 generation backK201799 CleaniCalMaruchi · 2021
- This deviceK212475 Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited · 2022
Show all 9 generations
- Root · 9 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 8 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 7 generations backK032268 MBCPBiomatlante · 2003
- 6 generations backK043005 Modification to MBCPBiomatlante · 2005
- 5 generations backK051885 MBCPBiomatlante · 2005
- 4 generations backK060732 MBCP GelBiomatlante · 2006
- 3 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 2 generations backK170175 Endoseal MtaMaruchi · 2018
- 1 generation backK201799 CleaniCalMaruchi · 2021
- This deviceK212475 Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −8 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −7 | K032268 | MBCP | Biomatlante | 2003 | — |
| −6 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −5 | K051885 | MBCP | Biomatlante | 2005 | — |
| −4 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −3 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| −1 | K201799 | CleaniCal | Maruchi | 2021 | — |
| 0 (this device) | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | 2022 | — |
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 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2004 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K201799 | CleaniCalSummary page 6…red. Calcigel remains a paste with another cured material being placed on top of it to seal it. CalUltra cures via a base catalyst reaction. Predicate Device: CleaniCal K201799 Additional Predicate Devices: Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559 Reference Devices: Cavios Calci… | 2021 |
| * | K970113 | Ultra-Blend PlusSummary page 6…l being placed on top of it to seal it. CalUltra cures via a base catalyst reaction. Predicate Device: CleaniCal K201799 Additional Predicate Devices: Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559 Reference Devices: Cavios Calcium Hydroxide Cavity Liner K111668 (for ingredients),), R… | 1997 |
| * | K150559 | Life Fast Set, Life Regular SetSummary page 6…alUltra cures via a base catalyst reaction. Predicate Device: CleaniCal K201799 Additional Predicate Devices: Ultra Blend Plus K970113, Life Regular Set/ Life Fast Set K150559 Reference Devices: Cavios Calcium Hydroxide Cavity Liner K111668 (for ingredients),), RMGI Low Viscosity K123265 (for ingredient… | 2015 |
| † | K111668 | Cavios Cavity Liner | 2011 |
| † | K123265 | Rmgi Low Viscosity | 2012 |
| † | K190091 | Diapaste | 2020 |
| † | K042769 | Adseal Root Canal Sealer | 2004 |
| † | K922721 | VLC Dycal II | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 45 ancestors has a recall of any class.
- 1 other device also cites its predicate K201799.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Apacal ART and is suitable for several indications including: * Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. * Indirect pulp capping or management of deep caries lesions, or * Direct pulp capping CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for…
Read the full statement (117 words)
Apacal ART and is suitable for several indications including:
* Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
* Indirect pulp capping or management of deep caries lesions, or
* Direct pulp capping
CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.
Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including:
* Indirect pulp capping or management of deep caries lesions, or
* Direct pulp capping
CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
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/K212475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212475: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212475
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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