510(k) · Cleared
ClearedMta Fillapex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angelus Industria DE Productos Odontologicos SA · KIF Resin, Root Canal Filling
Cleared on Apr 25, 2014 as substantially equivalent to K113568 (Paxmed International, 2012) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 25, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011009 (2001). 11 ancestors in all, the oldest K820215 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK011009 White Mta MaterialDentsply International · 2001
- 4 generations backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- 3 generations backK080203 Mta Root Canal SealerDentsply Interntional · 2008
- 2 generations backK112046 Mta AngelusAngelus Industria DE Productos Odontologicos · 2012
- 1 generation backK113568 Mta-FillapexPaxmed International · 2012
- This deviceK140247 Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014
- Descendant · cites it directly · 1 of its ownK172701 Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A · 2018
- Descendant · 2 generations on · 0 of its ownK190537 BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −4 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| −3 | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| −2 | K112046 | Mta Angelus | Angelus Industria DE Productos Odontologicos | 2012 | — |
| −1 | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| 0 (this device) | K140247 | Mta Fillapex | Angelus Industria DE Productos Odontologicos SA | 2014 | — |
| +1 | K172701 | Bio-C Sealer | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| +2 | K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K113568 | Mta-FillapexSummary page 2…Subject Device Predicate Device MTA Fillapex by Angelus K113568 MTA Fillapex by K(010940 Sealapex by ________________K140247… | 2012 |
| * | K010940 | Sealapex 4Summary page 2…e designated for the equivalent dental applications and have comparable chemical and physical properties, and performance specifications. An additional predicate device (K010940) includes each specific chemical component that is equivalent to those found in MTA Fillapex, providing evidence that these mater… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172701 | Bio-C Sealer | 2018 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K172701 (Angelus Industria DE Produtos Odontologicos S/A, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K113568.
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?
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140247: Mta Fillapex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140247
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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