510(k) · Cleared
ClearedMta Angelus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angelus Industria DE Productos Odontologicos · KIF Resin, Root Canal Filling
Cleared on Jan 6, 2012 as substantially equivalent to K073218 (Dentsply Interntional, 2008) and 2 other predicates after a 172-day review. Its family tree reaches back 3 generations to 2001. 15 later devices descend from it.
- Decided
- Jan 6, 2012
- Review
- 172 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011009 (2001). 15 later devices descend from it, 3 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 deviceK112046 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 · 3 generations on · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · cites it directly · 2 of its ownK151047 MTA Repair HPAngelus Industria DE Productos Odontologicos · 2016
- Descendant · 2 generations on · 2 of its ownK140247 Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113568Mta-FillapexPaxmed International · 2012 · cites it directly12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K201799CleaniCalMaruchi · 2021 · 3 generations on2descendants
- K151047MTA Repair HPAngelus Industria DE Productos Odontologicos · 2016 · cites it directly2descendants
- K140247Mta FillapexAngelus Industria DE Productos Odontologicos SA · 2014 · 2 generations on2descendants
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) | K112046 | Mta Angelus | Angelus Industria DE Productos Odontologicos | 2012 | — |
| +1 | K113568 | Mta-Fillapex | Paxmed International | 2012 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +1 | K151047 | MTA Repair HP | Angelus Industria DE Productos Odontologicos | 2016 | — |
| +2 | K140247 | Mta Fillapex | Angelus Industria DE Productos Odontologicos SA | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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? (3)
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 2…Angelus is substantially equivalent in indications and design principles to the following predicate devices: DENISPLY International, MTA Advanced Material cleared under K0732 18 and DENTSPLY International, White MTA Material cleared under K01 1009. DENTSPLY International, MITA Root Canal Sealer K080203 Th… | 2008 |
| * | K011009 | White Mta MaterialSummary page 2…es to the following predicate devices: DENISPLY International, MTA Advanced Material cleared under K0732 18 and DENTSPLY International, White MTA Material cleared under K01 1009. DENTSPLY International, MITA Root Canal Sealer K080203 The subject device and the predicate devices have the same or similar in… | 2001 |
| * | K080203 | Mta Root Canal SealerSummary page 2…ional, MTA Advanced Material cleared under K0732 18 and DENTSPLY International, White MTA Material cleared under K01 1009. DENTSPLY International, MITA Root Canal Sealer K080203 The subject device and the predicate devices have the same or similar intended use and have the same technological characteristi… | 2008 |
What descends from it? (15)
See all 153 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 11 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113568 (Paxmed International, 2012) has gone furthest, with 12 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. 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?
Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
Via canal treatment of root perforation due to internal resorption
Surgical treatment of root perforation due to internal resorption
Periapical surgery with reverse filling
Pulp capping
Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue)
Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112046: Mta Angelus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112046
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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