510(k) · Cleared
ClearedPulpdent Calcium Hydroxide Preparations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corp. · EJK Liner, Cavity, Calcium Hydroxide
Cleared on Nov 30, 1994 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 30, 1994
- Review
- 54 days
- Class
- Class II
- Product code
- EJK
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK944945 Pulpdent Calcium Hydroxide PreparationsPulpdent Corp. · 1994
- Descendant · cites it directly · 7 of its ownK032605 Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal…Meta Biomed Co., Ltd. · 2003
- Descendant · 2 generations on · 2 of its ownK210904 Metapaste PlusMeta Biomed Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK190091 DiapasteDiaDent Group International · 2020
- Descendant · 3 generations on · 1 of its ownK210333 DiaPasteDiaDent Group International · 2021
- Descendant · 3 generations on · 0 of its ownK261514 Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K032605Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal FillingMeta Biomed Co., Ltd. · 2003 · cites it directly7descendants
- K210904Metapaste PlusMeta Biomed Co., Ltd. · 2021 · 2 generations on2descendants
- K190091DiapasteDiaDent Group International · 2020 · 2 generations on2descendants
- K210333DiaPasteDiaDent Group International · 2021 · 3 generations on1descendant
- K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944945 | Pulpdent Calcium Hydroxide Preparations | Pulpdent Corp. | 1994 | — |
| +1 | K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling | Meta Biomed Co., Ltd. | 2003 | — |
| +2 | K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021 | — |
| +2 | K190091 | Diapaste | DiaDent Group International | 2020 | — |
| +3 | K210333 | DiaPaste | DiaDent Group International | 2021 | — |
| +3 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 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?
- Of its descendants, K032605 (Meta Biomed Co., Ltd., 2003) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K944945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944945: Pulpdent Calcium Hydroxide Preparations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944945
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026