510(k) · Cleared
ClearedNUCAL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Apr 5, 2012 as substantially equivalent to K944945 (Pulpdent Corp., 1994) after a 93-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 5, 2012
- Review
- 93 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K944945 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944945 Pulpdent Calcium Hydroxide PreparationsPulpdent Corp. · 1994
- This deviceK120003 NUCALPulpdent Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944945 | Pulpdent Calcium Hydroxide Preparations | Pulpdent Corp. | 1994 | — |
| 0 (this device) | K120003 | NUCAL | Pulpdent Corporation | 2012 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944945 | Pulpdent Calcium Hydroxide PreparationsSummary page 1…Cavity liner and temporary root Calcium hydroxide radiopaque calcium hydroxide canal dressing. Barium sulfate K944945 paste Aqueous gel matrix Pulpdent Mu/ti-Cal Non-set… | 1994 |
| Kept off the family tree | K094945 | Pulpdent Multi-Cal Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| Kept off the family tree | K901714 | FDA’s K901714 is Lifestyle Home Tanning Units Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K944945.
How does its category compare?
All EJK devicesEJK Liner, Cavity, Calcium Hydroxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste used as a cavity liner and as a temporary root canal dressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120003: NUCAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120003
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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