510(k) · Cleared
ClearedMTA2 Root and Pulp Materials
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 Dec 11, 2012 as substantially equivalent to K011009 (Dentsply International, 2001) and 1 other predicate after an 82-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011009 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK011009 White Mta MaterialDentsply International · 2001
- 2 generations backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- 1 generation backK080203 Mta Root Canal SealerDentsply Interntional · 2008
- This deviceK122892 MTA2 Root and Pulp MaterialsAvalon Biomed, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK140955 MTA2.1 MaterialAvalon Biomed, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK161239 MTA2.2 MaterialAvalon Biomed, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK181917 MTA2.3 MaterialsNuSmile, Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK241457 Vista BC PuttyInter-Med, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K140955MTA2.1 MaterialAvalon Biomed, Inc. · 2014 · cites it directly3descendants
- K161239MTA2.2 MaterialAvalon Biomed, Inc. · 2016 · 2 generations on2descendants
- K181917MTA2.3 MaterialsNuSmile, Ltd. · 2019 · 3 generations on1descendant
- K241457Vista BC PuttyInter-Med, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −2 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| −1 | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| 0 (this device) | K122892 | MTA2 Root and Pulp Materials | Avalon Biomed, Inc. | 2012 | — |
| +1 | K140955 | MTA2.1 Material | Avalon Biomed, Inc. | 2014 | — |
| +2 | K161239 | MTA2.2 Material | Avalon Biomed, Inc. | 2016 | — |
| +3 | K181917 | MTA2.3 Materials | NuSmile, Ltd. | 2019 | — |
| +4 | K241457 | Vista BC Putty | Inter-Med, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K011009 | White Mta MaterialSummary page 1…ed.com DATE PREPARED: November 27, 2012 TRADE OR PROPRIETARY NAME: MTA2 ROOT AND PULP MATERIALS CLASSIFICATION NAME: Root Canal Filling Resin 872.3820 PREDICATE DEVICES: K011009, White MTA Material and K080203, MTA root canal sealer DEVICE DESCRIPTION: The MTA2 ROOT AND PULP MATERIALS are designed and deve… | 2001 |
| * | K080203 | Mta Root Canal SealerSummary page 1…7, 2012 TRADE OR PROPRIETARY NAME: MTA2 ROOT AND PULP MATERIALS CLASSIFICATION NAME: Root Canal Filling Resin 872.3820 PREDICATE DEVICES: K011009, White MTA Material and K080203, MTA root canal sealer DEVICE DESCRIPTION: The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in den… | 2008 |
| † | K096174 | Unnamed device | |
| † | K980332 | Mta Material | 1998 |
| † | K981620 | Mta Material II | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140955 | MTA2.1 Material | 2014 | 3 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140955 (Avalon Biomed, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K011009.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ROOT AND PULP MATERIALS are intended for use in 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/K122892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122892: MTA2 Root and Pulp Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122892
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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