510(k) · Cleared
ClearedMta-Fillapex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paxmed International · KIF Resin, Root Canal Filling
Cleared on Aug 21, 2012 as substantially equivalent to K112046 (Angelus Industria DE Productos Odontologicos, 2012) and 6 other predicates after a 263-day review. Its family tree reaches back 4 generations to 2001. 12 later devices descend from it.
- Decided
- Aug 21, 2012
- Review
- 263 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K011009 (2001). 10 ancestors in all, the oldest K820215 (1982). 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK011009 White Mta MaterialDentsply International · 2001
- 3 generations backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- 2 generations backK080203 Mta Root Canal SealerDentsply Interntional · 2008
- 1 generation backK112046 Mta AngelusAngelus Industria DE Productos Odontologicos · 2012
- This deviceK113568 Mta-FillapexPaxmed International · 2012
- Descendant · cites it directly · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 2 generations on · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · cites it directly · 2 of its ownK140247 Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014
- Descendant · 2 generations on · 1 of its ownK202015 White ENDOSEAL MTAMaruchi · 2021
- Descendant · 2 generations on · 1 of its ownK172701 Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K170175Endoseal MtaMaruchi · 2018 · cites it directly8descendants
- K201799CleaniCalMaruchi · 2021 · 2 generations on2descendants
- K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014 · cites it directly2descendants
- K202015White ENDOSEAL MTAMaruchi · 2021 · 2 generations on1descendant
- K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −3 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| −2 | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| −1 | K112046 | Mta Angelus | Angelus Industria DE Productos Odontologicos | 2012 | — |
| 0 (this device) | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| +1 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +2 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +1 | K140247 | Mta Fillapex | Angelus Industria DE Productos Odontologicos SA | 2014 | — |
| +2 | K202015 | White ENDOSEAL MTA | Maruchi | 2021 | — |
| +2 | K172701 | Bio-C Sealer | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
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 |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K112046 | Mta Angelus Cleared while this submission was under review | 2012 |
| * | K080203 | Mta Root Canal SealerSummary page 2…ng root canal obturation. The device is provided non-sterile. EQUIVALENCE TO MARKETED DEVICE KI 12046 - Angelus Indlustria de Produtos Odlontologicos S/A, MTA Angelus, K080203 - Dentsply International, MTA ROOT CANAL SEALER, K820215 - Dentsply International, Improved Dycal, KO010940 - Sybron Dental Speci… | 2008 |
| * | K820215 | Improved DycalSummary page 2…ile. EQUIVALENCE TO MARKETED DEVICE KI 12046 - Angelus Indlustria de Produtos Odlontologicos S/A, MTA Angelus, K080203 - Dentsply International, MTA ROOT CANAL SEALER, K820215 - Dentsply International, Improved Dycal, KO010940 - Sybron Dental Specialties, Inc.,Sealapex 4, K 102163 - Sybron Dental Special… | 1982 |
| * | K010940 | Sealapex 4Summary page 2…tially equivalent to the predicate devices listed above. The design of the subject device (base/catalyst, two paste system) is similar to the devices cleared in K820215, K01 0940, K102163, and K893794. The intended use of the subject device is the same as the devices cleared in KI 12046, K080203, K01 0940,… | 2001 |
| * | K102163 | Realseal XT SealerSummary page 2…ngelus, K080203 - Dentsply International, MTA ROOT CANAL SEALER, K820215 - Dentsply International, Improved Dycal, KO010940 - Sybron Dental Specialties, Inc.,Sealapex 4, K 102163 - Sybron Dental Specialties, Inc., RealSeal XT Sealer, K893794 - Williams Dental Co. Apexit, and K063237 - Bisco, Inc., TheraCal… | 2010 |
| * | K893794 | Apexit Root Canal SealerSummary page 2…K820215 - Dentsply International, Improved Dycal, KO010940 - Sybron Dental Specialties, Inc.,Sealapex 4, K 102163 - Sybron Dental Specialties, Inc., RealSeal XT Sealer, K893794 - Williams Dental Co. Apexit, and K063237 - Bisco, Inc., TheraCal LC. The subject device is compositionally substantially equiva… | 1989 |
| * | K063237 | Theracal LCSummary page 2…d Dycal, KO010940 - Sybron Dental Specialties, Inc.,Sealapex 4, K 102163 - Sybron Dental Specialties, Inc., RealSeal XT Sealer, K893794 - Williams Dental Co. Apexit, and K063237 - Bisco, Inc., TheraCal LC. The subject device is compositionally substantially equivalent to the predicate devices listed above… | 2006 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K170175 (Maruchi, 2018) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K112046.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 sealing 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/K113568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113568: 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/K113568
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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