510(k) · Cleared
ClearedTheraCal DC
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 Aug 4, 2015 as substantially equivalent to K063237 (Bisco, Inc., 2006) after a 260-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 4, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922721 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922721 VLC Dycal IIDentsply Intl. · 1992
- 1 generation backK063237 Theracal LCBisco, Inc. · 2006
- This deviceK143292 TheraCal DCBisco, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK180344 TheraCal DCBisco, Inc. · 2018
- Descendant · 2 generations on · 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 |
|---|---|---|---|---|---|
| −2 | K922721 | VLC Dycal II | Dentsply Intl. | 1992 | — |
| −1 | K063237 | Theracal LC | Bisco, Inc. | 2006 | — |
| 0 (this device) | K143292 | TheraCal DC | Bisco, Inc. | 2015 | — |
| +1 | K180344 | TheraCal DC | Bisco, Inc. | 2018 | — |
| +2 | K211905 | UltraCal XS | Ultradent Products, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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 |
|---|---|---|---|
| * | K063237 | Theracal LCSummary page 4…Class II per 21 CFR 872.3250 Predicate Devices: TheraCal DC is substantially equivalent to: Primary Predicate: TheraCal LC by Bisco Inc. K063237 Reference Predicates: BioDentine by Septodont K140132 RMGI Low Viscosity (believed to be Activa… | 2006 |
| † | K140132 | Biodentine | 2014 |
| † | K123265 | Rmgi Low Viscosity | 2012 |
| † | K142178 | Proroot Mta White, Proroot Mta Gray | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180344 | TheraCal DC | 2018 | 1 |
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 2 companies; a new generation was cleared every 14.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180344 (Bisco, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K063237.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
TheraCal DC is indicated for use for:
1. Pulpotomy
2. Temporary filling material
3. Repair of root perforations
4. Repair of furcation perforations
5. Repair of perforating internal and external resorptions
6. Root-end filling in endodontic surgery
7. Pulp exposures (direct pulp capping)
8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143292 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143292: TheraCal DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143292
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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