510(k) · Cleared
ClearedTheracal LC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Dec 8, 2006 as substantially equivalent to K922721 (Dentsply Intl., 1992) after a 43-day review. Its family tree reaches back 1 generation to 1992. 18 later devices descend from it.
- Decided
- Dec 8, 2006
- Review
- 43 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922721 (1992). 18 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK922721 VLC Dycal IIDentsply Intl. · 1992
- This deviceK063237 Theracal LCBisco, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK113568 Mta-FillapexPaxmed International · 2012
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 3 generations on · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · cites it directly · 2 of its ownK143292 TheraCal DCBisco, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK140247 Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K113568Mta-FillapexPaxmed International · 2012 · cites it directly12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K201799CleaniCalMaruchi · 2021 · 3 generations on2descendants
- K143292TheraCal DCBisco, Inc. · 2015 · cites it directly2descendants
- K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922721 | VLC Dycal II | Dentsply Intl. | 1992 | — |
| 0 (this device) | K063237 | Theracal LC | Bisco, Inc. | 2006 | — |
| +1 | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +1 | K143292 | TheraCal DC | Bisco, Inc. | 2015 | — |
| +2 | K140247 | Mta Fillapex | Angelus Industria DE Productos Odontologicos SA | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K922721 | VLC Dycal IISummary page 1…be used as a liner and pulp capping material. Its physical properties and uses are similar to the predicate device. Predicate Devices: Prisma VLC Dycal cleared under (K922721) dated July 23, 1992. Significant Performance Characteristics: Prisma VLC Dycal… | 1992 |
What descends from it? (18)
See all 184 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, K113568 (Paxmed International, 2012) has gone furthest, with 12 descendants of its own.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. Liner
2. Pulp capping agent
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063237: Theracal LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063237
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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