510(k) · Cleared
ClearedWhite Mta Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International · KIF Resin, Root Canal Filling
Cleared on May 2, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.
- Decided
- May 2, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 6 citing it directly.
- This deviceK011009 White Mta MaterialDentsply International · 2001
- Descendant · cites it directly · 38 of its ownK063422 BioaggregateInnovative Bioceramix, Inc. · 2006
- Descendant · 2 generations on · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · cites it directly · 22 of its ownK073218 Mta Advanced MaterialDentsply Interntional · 2008
- Descendant · 2 generations on · 21 of its ownK080203 Mta Root Canal SealerDentsply Interntional · 2008
- Descendant · cites it directly · 15 of its ownK112046 Mta AngelusAngelus Industria DE Productos Odontologicos · 2012
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K063422BioaggregateInnovative Bioceramix, Inc. · 2006 · cites it directly38descendants
- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · 2 generations on37descendants
- K073218Mta Advanced MaterialDentsply Interntional · 2008 · cites it directly22descendants
- K080203Mta Root Canal SealerDentsply Interntional · 2008 · 2 generations on21descendants
- K112046Mta AngelusAngelus Industria DE Productos Odontologicos · 2012 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011009 | White Mta Material | Dentsply International | 2001 | — |
| +1 | K063422 | Bioaggregate | Innovative Bioceramix, Inc. | 2006 | — |
| +2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (57)
See all 576 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?
- Of its descendants, K063422 (Innovative Bioceramix, Inc., 2006) has gone furthest, with 38 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.
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 | — |
https://510kreport.com/device/K011009 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011009: White Mta Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026