510(k) · Cleared
ClearedPulpdent Calcium Hydroxide Preparation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · KIF Resin, Root Canal Filling
Cleared on Oct 7, 2002 after a 52-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Oct 7, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK022734 Pulpdent Calcium Hydroxide PreparationPulpdent Corporation · 2002
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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) | K022734 | Pulpdent Calcium Hydroxide Preparation | Pulpdent Corporation | 2002 | — |
| +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 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2026 | 2 | 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 KIF? 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 KIF device
- #1 K250710 Injectable Root Canal Bioceramic Sealer (nRoot…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Neo/Diadent Vitapex Calcium Hydroxide Paste Named without a submission number | |
| * | — | ROEKO RSA RoekoSeal Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling | 2003 | 7 |
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 KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KIF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KIF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIF
55in 2025
MAUDE reports naming product code KIF, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 31 | 0 | 2 |
| 2009 | 5 | 94 | 1 | 7 |
| 2010 | 5 | 75 | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 5 | 172 | 0 | 4 |
| 2013 | 2 | — | 0 | 79 |
| 2014 | 10 | 220 | 0 | 421 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 5 | 212 | 0 | 5 |
| 2017 | 3 | 211 | 0 | 5 |
| 2018 | 5 | 147 | 0 | 13 |
| 2019 | 7 | 252 | 0 | 6 |
| 2020 | 3 | 239 | 0 | 3 |
| 2021 | 12 | 89 | 0 | 9 |
| 2022 | 3 | 152 | 0 | 10 |
| 2023 | 7 | 59 | 0 | 7 |
| 2024 | 8 | 96 | 0 | 10 |
| 2025 | 7 | 90 | 0 | 55 |
| 2026 | 7 | 108 | 0 | — |
What is it indicated for?
PULPDENT CALCIUM HYDROXIDE PREPARA TlON is a biocompatible polydimethylsiloxane-based root canal sealer used for the temporary and permanent filling of root canals after endodontic surgery. PULPDENT CALCIUM HYDROXIDE PREPARATION can be used on its own, in conjunction with Gutta Percha and for vital pulpdectomies in deciduous teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022734: Pulpdent Calcium Hydroxide Preparation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022734
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