510(k) · Cleared
ClearedDia-Root Bio Mta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · KIF Resin, Root Canal Filling
Cleared on Sep 18, 2020 as substantially equivalent to K112046 (Angelus Industria DE Productos Odontologicos, 2012) after a 239-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011009 (2001). 1 later device descends 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 deviceK200174 Dia-Root Bio MtaDiaDent Group International · 2020
- Descendant · cites it directly · 0 of its ownK211905 UltraCal XSUltradent Products, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211905UltraCal XSUltradent Products, Inc. · 2021 · cites it directly0descendants
View 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) | K200174 | Dia-Root Bio Mta | DiaDent Group International | 2020 | — |
| +1 | K211905 | UltraCal XS | Ultradent Products, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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…DIA-ROOT BIO MTA 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K112046 Applicant: ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS Device Name: MTA ANGELU… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211905 | UltraCal XS | 2021 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K211905 (Ultradent Products, Inc., 2021) has gone furthest, with 0 descendants 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. 2020, 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?
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.
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/K200174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200174: Dia-Root Bio Mta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200174
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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