510(k) · Cleared
ClearedRetromta-Orthomta II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomta · KIF Resin, Root Canal Filling
Cleared on Apr 10, 2014 as substantially equivalent to K102575 (Do Co., Ltd., 2010) after a 213-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Apr 10, 2014
- Review
- 213 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011009 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011009 White Mta MaterialDentsply International · 2001
- 1 generation backK102575 Ortho Mta (Mineral Trioxide Aggregate)Do Co., Ltd. · 2010
- This deviceK132825 Retromta-Orthomta IIBiomta · 2014
- Descendant · cites it directly · 0 of its ownK230797 SmartMTA CapsuleSprig Oral Health Technologies, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230797SmartMTA CapsuleSprig Oral Health Technologies, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011009 | White Mta Material | Dentsply International | 2001 | — |
| −1 | K102575 | Ortho Mta (Mineral Trioxide Aggregate) | Do Co., Ltd. | 2010 | — |
| 0 (this device) | K132825 | Retromta-Orthomta II | Biomta | 2014 | — |
| +1 | K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102575 | Ortho Mta (Mineral Trioxide Aggregate)Summary page 1…esin Classification: Class 11,21 CER 872.3820 Classification Product Code: KIF 4. Predicate Device: OrthoMTA(K 102575) by BioMTA 1 5. Device Description: The major compo… | 2010 |
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 |
|---|---|---|---|
| K230797 | SmartMTA Capsule | 2023 | 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 13 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230797 (Sprig Oral Health Technologies, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 RetroMTA-OrthovTA His indicated for use as:
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy(endlodontic therapy), or as a consequence of internal and external resorption.
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132825 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132825: Retromta-Orthomta II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132825
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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