510(k) · Cleared
ClearedMta Root Canal Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · KIF Resin, Root Canal Filling
Cleared on Mar 26, 2008 as substantially equivalent to K073218 (Dentsply Interntional, 2008) after a 58-day review. Its family tree reaches back 2 generations to 2001. 21 later devices descend from it.
- Decided
- Mar 26, 2008
- Review
- 58 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011009 (2001). 21 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011009 White Mta MaterialDentsply International · 2001
- 1 generation backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- This deviceK080203 Mta Root Canal SealerDentsply Interntional · 2008
- Descendant · cites it directly · 15 of its ownK112046 Mta AngelusAngelus Industria DE Productos Odontologicos · 2012
- Descendant · cites it directly · 12 of its ownK113568 Mta-FillapexPaxmed International · 2012
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · cites it directly · 4 of its ownK122892 MTA2 Root and Pulp MaterialsAvalon Biomed, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK140955 MTA2.1 MaterialAvalon Biomed, Inc. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K112046Mta AngelusAngelus Industria DE Productos Odontologicos · 2012 · cites it directly15descendants
- K113568Mta-FillapexPaxmed International · 2012 · cites it directly12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K122892MTA2 Root and Pulp MaterialsAvalon Biomed, Inc. · 2012 · cites it directly4descendants
- K140955MTA2.1 MaterialAvalon Biomed, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −1 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| 0 (this device) | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| +1 | K112046 | Mta Angelus | Angelus Industria DE Productos Odontologicos | 2012 | — |
| +1 | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +1 | K122892 | MTA2 Root and Pulp Materials | Avalon Biomed, Inc. | 2012 | — |
| +2 | K140955 | MTA2.1 Material | Avalon Biomed, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K073218 | Mta Advanced MaterialSummary page 1…LER CLASSIFICATION NAME: Root canal filling resin (872.3820, KIF) PREDICATE DEVICES: MTA Advanced Material K073218 DEVICE DESCRIPTION: The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder an… | 2008 |
What descends from it? (21)
See all 213 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 7 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112046 (Angelus Industria DE Productos Odontologicos, 2012) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K073218.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080203: Mta Root Canal Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080203
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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