510(k) · Cleared
ClearedEndoseal Mta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maruchi · KIF Resin, Root Canal Filling
Cleared on Feb 26, 2018 as substantially equivalent to K133054 (Maruchi, 2014) and 2 other predicates after a 403-day review. Its family tree reaches back 7 generations to 1999. 8 later devices descend from it.
- Decided
- Feb 26, 2018
- Review
- 403 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K990131 (1999). 39 ancestors in all, the oldest K820215 (1982). 8 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 6 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 5 generations backK032268 MBCPBiomatlante · 2003
- 4 generations backK043005 Modification to MBCPBiomatlante · 2005
- 3 generations backK051885 MBCPBiomatlante · 2005
- 2 generations backK060732 MBCP GelBiomatlante · 2006
- 1 generation backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- This deviceK170175 Endoseal MtaMaruchi · 2018
- Descendant · cites it directly · 2 of its ownK201799 CleaniCalMaruchi · 2021
- Descendant · cites it directly · 1 of its ownK202015 White ENDOSEAL MTAMaruchi · 2021
- Descendant · cites it directly · 0 of its ownK231480 Bright MTA Sealer PlusGenoss Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221811 Vista BC SealerInter-Med, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK212563 CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra…Prevest Denpro Limited · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201799CleaniCalMaruchi · 2021 · cites it directly2descendants
- K202015White ENDOSEAL MTAMaruchi · 2021 · cites it directly1descendant
- K231480Bright MTA Sealer PlusGenoss Co., Ltd. · 2023 · cites it directly0descendants
- K221811Vista BC SealerInter-Med, Inc. · 2022 · cites it directly0descendants
- K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −6 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −5 | K032268 | MBCP | Biomatlante | 2003 | — |
| −4 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −3 | K051885 | MBCP | Biomatlante | 2005 | — |
| −2 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −1 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| 0 (this device) | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +1 | K201799 | CleaniCal | Maruchi | 2021 | — |
| +1 | K202015 | White ENDOSEAL MTA | Maruchi | 2021 | — |
| +1 | K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | 2023 | — |
| +1 | K221811 | Vista BC Sealer | Inter-Med, Inc. | 2022 | — |
| +1 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical… | Prevest Denpro Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133054 | EndosealSummary page 4…ng Resin Classification: Class II, 21 CFR 872.3820 Classification Product Code: KIF 4. Predicate Device: ENDOSEAL (K133054) by MARUCHI MTA Fillapex (K113568) by Angelus Industria de Produtos Odontologicos IROOT SP (K080917) by Innovative… | 2014 |
| * | K113568 | Mta-FillapexSummary page 4…Class II, 21 CFR 872.3820 Classification Product Code: KIF 4. Predicate Device: ENDOSEAL (K133054) by MARUCHI MTA Fillapex (K113568) by Angelus Industria de Produtos Odontologicos IROOT SP (K080917) by Innovative BioCeramix Inc.… | 2012 |
| * | K080917 | Iroot SPSummary page 4…KIF 4. Predicate Device: ENDOSEAL (K133054) by MARUCHI MTA Fillapex (K113568) by Angelus Industria de Produtos Odontologicos IROOT SP (K080917) by Innovative BioCeramix Inc. Page 1 of 5 5. Device Descripti… | 2008 |
What descends from it? (8)
5 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 19 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 39 ancestors has a recall of any class.
- Of its descendants, K201799 (Maruchi, 2021) has gone furthest, with 2 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. 2018, 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?
Permanent obturation of the root canal following vital pulp-extirpation
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170175: Endoseal Mta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170175
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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