510(k) · Cleared
ClearedEndocem Mta (Mineral Trioxide Aggregate)
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 Mar 19, 2012 as substantially equivalent to K981620 (Dentsply Intl., 1998) after a 242-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Mar 19, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964174 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK964174 Mineral Trioxide Aggregate (Mta)Tulsa Dental Products, Ltd. · 1997
- 2 generations backK980332 Mta MaterialDentsply Intl. · 1998
- 1 generation backK981620 Mta Material IIDentsply Intl. · 1998
- This deviceK112078 Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012
- Descendant · cites it directly · 0 of its ownK133042 Endocem ZRMaruchi · 2014
Most influential descendants
Showing 1 of 1 · See all- K133042Endocem ZRMaruchi · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964174 | Mineral Trioxide Aggregate (Mta) | Tulsa Dental Products, Ltd. | 1997 | — |
| −2 | K980332 | Mta Material | Dentsply Intl. | 1998 | — |
| −1 | K981620 | Mta Material II | Dentsply Intl. | 1998 | — |
| 0 (this device) | K112078 | Endocem Mta (Mineral Trioxide Aggregate) | Maruchi | 2012 | — |
| +1 | K133042 | Endocem ZR | Maruchi | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981620 | Mta Material IISummary page 1…me: Root canal filling resin *Classification regulation: 21 CER 872.3820 *Product Code: KIF 4. Predicate Device MTA MATERIAL (K981620), Dentsply International 5. Description: This product is designed for vital pulp therapies like direct pulp cap… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133042 | Endocem ZR | 2014 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133042 (Maruchi, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981620.
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?
A root-end filling material
For the repair of root canals as an apical plug during apexification
For repair of root perforations during root canal therapy
As a consequence of internal resorption
As a pulp capping material
For the filling of pulpotomy of deciduous tooth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112078: Endocem Mta (Mineral Trioxide Aggregate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112078
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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