510(k) · Cleared
ClearedMTA2.2 Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avalon Biomed, Inc. · KIF Resin, Root Canal Filling
Cleared on Sep 1, 2016 as substantially equivalent to K140955 (Avalon Biomed, Inc., 2014) after a 122-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 1, 2016
- Review
- 122 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011009 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK011009 White Mta MaterialDentsply International · 2001
- 4 generations backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- 3 generations backK080203 Mta Root Canal SealerDentsply Interntional · 2008
- 2 generations backK122892 MTA2 Root and Pulp MaterialsAvalon Biomed, Inc. · 2012
- 1 generation backK140955 MTA2.1 MaterialAvalon Biomed, Inc. · 2014
- This deviceK161239 MTA2.2 MaterialAvalon Biomed, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK181917 MTA2.3 MaterialsNuSmile, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK241457 Vista BC PuttyInter-Med, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −4 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| −3 | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| −2 | K122892 | MTA2 Root and Pulp Materials | Avalon Biomed, Inc. | 2012 | — |
| −1 | K140955 | MTA2.1 Material | Avalon Biomed, Inc. | 2014 | — |
| 0 (this device) | K161239 | MTA2.2 Material | Avalon Biomed, Inc. | 2016 | — |
| +1 | K181917 | MTA2.3 Materials | NuSmile, Ltd. | 2019 | — |
| +2 | K241457 | Vista BC Putty | Inter-Med, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K140955 | MTA2.1 MaterialSummary page 4…www.avalonbiomed.com/ II. DEVICE TRADE OR PROPRIETARY NAME: MTA2.2 MATERIAL CLASSIFICATION NAME: Root Canal Filling Resin 872.3820 class II PREDICATE DEVICE: K140955, MTA2.1 ROOT AND PULP MATERIALS III. PREDICATE DEVICES MTA 2.2 MATERIAL IS substantially equivalent to the following predicate d… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181917 | MTA2.3 Materials | 2019 | 1 |
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 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K181917 (NuSmile, Ltd., 2019) has gone furthest, with 1 descendant 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. 2016, 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?
The MTA2.2 MATERIAL is intended for use for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161239: MTA2.2 Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161239
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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