510(k) · Cleared
ClearedMTA Repair HP
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 Aug 31, 2016 as substantially equivalent to K112046 (Angelus Industria DE Productos Odontologicos, 2012) after a 499-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 31, 2016
- Review
- 499 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011009 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK011009 White Mta MaterialDentsply International · 2001
- 3 generations backK073218 Mta Advanced MaterialDentsply Interntional · 2008
- 2 generations backK080203 Mta Root Canal SealerDentsply Interntional · 2008
- 1 generation backK112046 Mta AngelusAngelus Industria DE Productos Odontologicos · 2012
- This deviceK151047 MTA Repair HPAngelus Industria DE Productos Odontologicos · 2016
- Descendant · cites it directly · 1 of its ownK172701 Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A · 2018
- Descendant · 2 generations on · 0 of its ownK190537 BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A · 2019
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 |
|---|---|---|---|---|---|
| −4 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −3 | K073218 | Mta Advanced Material | Dentsply Interntional | 2008 | — |
| −2 | K080203 | Mta Root Canal Sealer | Dentsply Interntional | 2008 | — |
| −1 | K112046 | Mta Angelus | Angelus Industria DE Productos Odontologicos | 2012 | — |
| 0 (this device) | K151047 | MTA Repair HP | Angelus Industria DE Productos Odontologicos | 2016 | — |
| +1 | K172701 | Bio-C Sealer | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| +2 | K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K112046 | Mta AngelusSummary page 4…KIF Classification Panel: Dental Regulation Numbers: 21 CFR 872.3820 Substantial Equivalence: (K112046) MTA-Angelus Indications for Use: • Treatment of perforations of root canal and furcation caused iatrogenically or by caries… | 2012 |
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 |
|---|---|---|---|
| K172701 | Bio-C Sealer | 2018 | 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 4.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172701 (Angelus Industria DE Produtos Odontologicos S/A, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K112046.
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?
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 crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151047: MTA Repair HP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151047
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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