510(k) · Cleared
ClearedMta Material II
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 Jul 31, 1998 as substantially equivalent to K964174 (Tulsa Dental Products, Ltd., 1997) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Jul 31, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964174 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK964174 Mineral Trioxide Aggregate (Mta)Tulsa Dental Products, Ltd. · 1997
- 1 generation backK980332 Mta MaterialDentsply Intl. · 1998
- This deviceK981620 Mta Material IIDentsply Intl. · 1998
- Descendant · cites it directly · 3 of its ownK142178 Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK112078 Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012
- Descendant · 2 generations on · 0 of its ownK252285 Well-Root PTVericom Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK162661 SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142178Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015 · cites it directly3descendants
- K112078Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012 · cites it directly1descendant
- K252285Well-Root PTVericom Co., Ltd. · 2025 · 2 generations on0descendants
- K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc. · 2022 · 2 generations on0descendants
- K162661SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964174 | Mineral Trioxide Aggregate (Mta) | Tulsa Dental Products, Ltd. | 1997 | — |
| −1 | K980332 | Mta Material | Dentsply Intl. | 1998 | — |
| 0 (this device) | K981620 | Mta Material II | Dentsply Intl. | 1998 | — |
| +1 | K142178 | Proroot Mta White, Proroot Mta Gray | Dentsply International, Inc. | 2015 | — |
| +1 | K112078 | Endocem Mta (Mineral Trioxide Aggregate) | Maruchi | 2012 | — |
| +2 | K252285 | Well-Root PT | Vericom Co., Ltd. | 2025 | — |
| +2 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair… | Innovative Bioceramix, Inc. | 2022 | — |
| +2 | K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | 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 MTA Material K980332 DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended… | 1997 |
| * | K980332 | Mta MaterialSummary page 1…N OR USUAL NAME: Root Filling Material CLASSIFICATION NAME: Root canal filling resin material 872.3820 PREDICATE DEVICE: Mineral Trioxide Aggregate K964174 MTA Material K980332 DEVICE DESCRIPTION: MTA MATERIAL is identical to K964174 and K980332. This submission is for a new intended use. & MTA MATERIA… | 1998 |
What descends from it? (6)
2 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 1 year and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142178 (Dentsply International, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K964174.
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 Il is indicated for use as a root end filling material.
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/K981620 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981620: Mta Material II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981620
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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