510(k) · Cleared
ClearedEndoseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maruchi · KIF Resin, Root Canal Filling
Cleared on May 12, 2014 after a 227-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 9 later devices descend from it.
- Decided
- May 12, 2014
- Review
- 227 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
9 later devices descend from it, 1 citing it directly.
- This deviceK133054 EndosealMaruchi · 2014
- Descendant · cites it directly · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 2 generations on · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · 2 generations on · 1 of its ownK202015 White ENDOSEAL MTAMaruchi · 2021
- Descendant · 2 generations on · 0 of its ownK231480 Bright MTA Sealer PlusGenoss Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK221811 Vista BC SealerInter-Med, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K170175Endoseal MtaMaruchi · 2018 · cites it directly8descendants
- K201799CleaniCalMaruchi · 2021 · 2 generations on2descendants
- K202015White ENDOSEAL MTAMaruchi · 2021 · 2 generations on1descendant
- K231480Bright MTA Sealer PlusGenoss Co., Ltd. · 2023 · 2 generations on0descendants
- K221811Vista BC SealerInter-Med, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133054 | Endoseal | Maruchi | 2014 | — |
| +1 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +2 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +2 | K202015 | White ENDOSEAL MTA | Maruchi | 2021 | — |
| +2 | K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023 | — |
| +2 | K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K120078 | FDA’s K120078 is Healix Advance BR Anchor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170175 | Endoseal Mta | 2018 | 8 |
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, K170175 (Maruchi, 2018) has gone furthest, with 8 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. 2014, 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?
Repair of perforation
Root canal filling
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133054: Endoseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133054
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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