510(k) · Cleared
ClearedCalcium Hydroxide Temporary Filling Material (KP-Cal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Kevin Peter Technology Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Aug 25, 2026 as substantially equivalent to K210904 (Meta Biomed Co., Ltd., 2021) and 1 other predicate after a 110-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 25, 2026
- Review
- 110 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944945 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944945 Pulpdent Calcium Hydroxide PreparationsPulpdent Corp. · 1994
- 2 generations backK032605 Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal…Meta Biomed Co., Ltd. · 2003
- 1 generation backK210904 Metapaste PlusMeta Biomed Co., Ltd. · 2021
- This deviceK261514 Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944945 | Pulpdent Calcium Hydroxide Preparations | Pulpdent Corp. | 1994 | — |
| −2 | K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling | Meta Biomed Co., Ltd. | 2003 | — |
| −1 | K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021 | — |
| 0 (this device) | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 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 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 |
|---|---|---|---|
| * | K210904 | Metapaste PlusSummary page 5…ulation Number： 21 CFR 872.3820 Device Class: Class II Product Code： KIF 3.0 Identification of Predicate Device Primary Predicate Device 510(k) Number: K210904 Device Name: Metapaste Plus Common Name: Root Canal Filling Resin Panel: Dental Regulation Number: 21 CFR… | 2021 |
| * | K060365 | ApexcalSummary page 6…ct Code： KIF Manufacturer: Meta Biomed Co.,Ltd 1/6 Reference Predicate Device: 510(k) Number: K060365 Device Name: Calcium hydroxide paste Common Name: Calcium hydroxide cavity liner Model: ApexCal Panel… | 2006 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K210904.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
Calcium Hydroxide Temporary Filling Material is suitable for several indications including：
-Temporary root canal filling;
-Vital pulpotomy
-Temporary pulp capping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261514: Calcium Hydroxide Temporary Filling Material (KP-Cal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261514
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026