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 Apr 5, 2018 as substantially equivalent to K143292 (Bisco, Inc., 2015) after a 56-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Apr 5, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922721 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922721 VLC Dycal IIDentsply Intl. · 1992
- 2 generations backK063237 Theracal LCBisco, Inc. · 2006
- 1 generation backK143292 TheraCal DCBisco, Inc. · 2015
- This deviceK180344 TheraCal DCBisco, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK211905 UltraCal XSUltradent Products, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211905UltraCal XSUltradent Products, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922721 | VLC Dycal II | Dentsply Intl. | 1992 | — |
| −2 | K063237 | Theracal LC | Bisco, Inc. | 2006 | — |
| −1 | K143292 | TheraCal DC | Bisco, Inc. | 2015 | — |
| 0 (this device) | K180344 | TheraCal DC | Bisco, Inc. | 2018 | — |
| +1 | K211905 | UltraCal XS | Ultradent Products, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143292 | TheraCal DCSummary page 4…Class II per 21 CFR 872.3250 Predicate Devices: TheraCal DC is substantially equivalent to: Primary Predicate: TheraCal DC by Bisco Inc. K143292 TheraCal DC is indicated for use for: 1. Pulpotomy 2. Temporary Filling Material 3. Repair of Root Perforations 4.… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211905 | UltraCal XS | 2021 | 0 |
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 26 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211905 (Ultradent Products, Inc., 2021) has gone furthest, with 0 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. 2018, 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?
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/K180344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180344: 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/K180344
Report an extraction error
Are you the manufacturer?
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