510(k) · Cleared
ClearedMta Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KIF Resin, Root Canal Filling
Cleared on Feb 24, 1998 as substantially equivalent to K964174 (Tulsa Dental Products, Ltd., 1997) after a 27-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.
- Decided
- Feb 24, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964174 (1997). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964174 Mineral Trioxide Aggregate (Mta)Tulsa Dental Products, Ltd. · 1997
- This deviceK980332 Mta MaterialDentsply Intl. · 1998
- Descendant · cites it directly · 6 of its ownK981620 Mta Material IIDentsply Intl. · 1998
- Descendant · 2 generations on · 3 of its ownK142178 Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK112078 Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012
- Descendant · 3 generations on · 0 of its ownK252285 Well-Root PTVericom Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981620Mta Material IIDentsply Intl. · 1998 · cites it directly6descendants
- K142178Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015 · 2 generations on3descendants
- K112078Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012 · 2 generations on1descendant
- K252285Well-Root PTVericom Co., Ltd. · 2025 · 3 generations on0descendants
- K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964174 | Mineral Trioxide Aggregate (Mta) | Tulsa Dental Products, Ltd. | 1997 | — |
| 0 (this device) | K980332 | Mta Material | Dentsply Intl. | 1998 | — |
| +1 | K981620 | Mta Material II | Dentsply Intl. | 1998 | — |
| +2 | K142178 | Proroot Mta White, Proroot Mta Gray | Dentsply International, Inc. | 2015 | — |
| +2 | K112078 | Endocem Mta (Mineral Trioxide Aggregate) | Maruchi | 2012 | — |
| +3 | K252285 | Well-Root PT | Vericom Co., Ltd. | 2025 | — |
| +3 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair… | Innovative Bioceramix, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K964174 | Mineral Trioxide Aggregate (Mta)Summary page 1…MTA MATERIAL COMMON OR USUAL NAME: Root Filling Material CLASSIFICATION NAME: Root canal filling resin material 872.3820 PREDICATE DEVICE: Mineral Trioxide Aggregate K964174 DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174, Mineral Trioxide Aggregate (found substantially equivalent February 10… | 1997 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981620 | Mta Material II | 1998 | 6 |
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?
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 | — |
What is it indicated for?
MTA MATERIAL is indicated for the repair of root canals as an apical plug during Apexification, and repair of Root Perforations during root canal therapy (endodontic therapy) or as a consequence of internal resorption.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980332: 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/K980332
Report an extraction error
Are you the manufacturer?
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