510(k) · Cleared
ClearedProroot Mta White, Proroot Mta Gray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · KIF Resin, Root Canal Filling
Cleared on Feb 26, 2015 as substantially equivalent to K011009 (Dentsply International, 2001) and 1 other predicate after a 202-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Feb 26, 2015
- Review
- 202 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964174 (1997). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK964174 Mineral Trioxide Aggregate (Mta)Tulsa Dental Products, Ltd. · 1997
- 2 generations backK980332 Mta MaterialDentsply Intl. · 1998
- 1 generation backK981620 Mta Material IIDentsply Intl. · 1998
- This deviceK142178 Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK252285 Well-Root PTVericom Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK162661 SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K252285Well-Root PTVericom Co., Ltd. · 2025 · cites it directly0descendants
- K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc. · 2022 · cites it directly0descendants
- K162661SavDenTM MTA Root Canal Filling MaterialsTyds Biotech Incorporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964174 | Mineral Trioxide Aggregate (Mta) | Tulsa Dental Products, Ltd. | 1997 | — |
| −2 | K980332 | Mta Material | Dentsply Intl. | 1998 | — |
| −1 | K981620 | Mta Material II | Dentsply Intl. | 1998 | — |
| 0 (this device) | K142178 | Proroot Mta White, Proroot Mta Gray | Dentsply International, Inc. | 2015 | — |
| +1 | K252285 | Well-Root PT | Vericom Co., Ltd. | 2025 | — |
| +1 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair… | Innovative Bioceramix, Inc. | 2022 | — |
| +1 | K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K011009 | White Mta MaterialSummary page 4…canal filling e CFR Number: 872.3850 e Device Class: 11 e Product Code: KIF 5.3 Predicate Devices: Predicate Device Name 510(k) S.E. Date Company Name White MTA Material K011009 May 2, 2001 DENTSPLY International, Inc. MTA Material II K981260 July 31, 1998 DENTSPLY International, Inc. 54 Description of D… | 2001 |
| * | K981620 | Mta Material II Our OCR of the scanned summary read K981260, FDA’s number for Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi… (Clinical Innovations, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “MTA Material II”. | 1998 |
What descends from it? (3)
3 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 18 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252285 (Vericom Co., Ltd., 2025) has gone furthest, with 0 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. 2015, 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?
A root end filling material
For the repair of repair of root canals as an apical plug during apexification
For repair of root perforations during root canal therapy or as a consequence of internal resorption
As a pulp capping material
Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations
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/K142178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142178: Proroot Mta White, Proroot Mta Gray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142178
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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