510(k) · Cleared
ClearedRealseal XT Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corporation · KIF Resin, Root Canal Filling
Cleared on Oct 16, 2010 after a 75-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Oct 16, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK102163 Realseal XT SealerKerr Corporation · 2010
- Descendant · cites it directly · 12 of its ownK113568 Mta-FillapexPaxmed International · 2012
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 3 generations on · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · 2 generations on · 2 of its ownK140247 Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014
- Descendant · 3 generations on · 1 of its ownK202015 White ENDOSEAL MTAMaruchi · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K113568Mta-FillapexPaxmed International · 2012 · cites it directly12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K201799CleaniCalMaruchi · 2021 · 3 generations on2descendants
- K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014 · 2 generations on2descendants
- K202015White ENDOSEAL MTAMaruchi · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102163 | Realseal XT Sealer | Kerr Corporation | 2010 | — |
| +1 | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +2 | K140247 | Mta Fillapex | Angelus Industria DE Productos Odontologicos SA | 2014 | — |
| +3 | K202015 | White ENDOSEAL MTA | Maruchi | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | — | SE Epiphany Root Canal Sealant Named without a submission number | |
| * | — | AH Plus Root Canal Sealer Named without a submission number |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113568 | Mta-Fillapex | 2012 | 12 |
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, K113568 (Paxmed International, 2012) has gone furthest, with 12 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. 2010, 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?
RealSeal XTSealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102163: Realseal XT Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102163
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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