510(k) · Cleared
ClearedIroot FS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Bioceramix, Inc. · KIF Resin, Root Canal Filling
Cleared on Dec 3, 2010 as substantially equivalent to K082943 (Innovative Bioceramix, Inc., 2009) and 3 other predicates after a 64-day review. Its family tree reaches back 9 generations to 1999. 2 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K990131 (1999). 37 ancestors in all, the oldest K851606 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 5 generations between
- 3 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 2 generations backK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- 1 generation backK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- This deviceK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK213757 Endocem MTA Premixed RegularMaruchi · 2023
- Descendant · cites it directly · 0 of its ownK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 8 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 7 generations backK032268 MBCPBiomatlante · 2003
- 6 generations backK043005 Modification to MBCPBiomatlante · 2005
- 5 generations backK051885 MBCPBiomatlante · 2005
- 4 generations backK060732 MBCP GelBiomatlante · 2006
- 3 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 2 generations backK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- 1 generation backK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- This deviceK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
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 |
|---|---|---|---|---|---|
| −9 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −8 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −7 | K032268 | MBCP | Biomatlante | 2003 | — |
| −6 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −5 | K051885 | MBCP | Biomatlante | 2005 | — |
| −4 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −3 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| −1 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| 0 (this device) | K102867 | Iroot FS | Innovative Bioceramix, Inc. | 2010 | — |
| +1 | K213757 | Endocem MTA Premixed Regular | Maruchi | 2023 | — |
| +1 | K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair… | Innovative Bioceramix, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K082943 | Iroot BP, Model Irbp 4609Summary page 1…SSIFICATION Resin, Root Canal Filling (21 CER 872.3820, Product Code: MEF) NAME: PREDICATE DEVICES: * iRoot BP .(K082943) * iRoot BP Plus (K0927 15) a iRoot S… | 2009 |
| * | K092715 | Iroot BP PlusSummary page 1…F) NAME: PREDICATE DEVICES: * iRoot BP .(K082943) * iRoot BP Plus (K0927 15) a iRoot SP (K080917) * D-PBS, Pr… | 2009 |
| * | K080917 | Iroot SPSummary page 1…82943) * iRoot BP Plus (K0927 15) a iRoot SP (K080917) * D-PBS, Products No. D5652 (K85 1606) DEVICE iRoot FS Fa… | 2008 |
| * | K851606 | D-PBS, Products NO. D5652Summary page 1…0927 15) a iRoot SP (K080917) * D-PBS, Products No. D5652 (K85 1606) DEVICE iRoot FS Fast Set Root Repair Material (iRoot ES) is a convenient ready-to- DESCRIPTION:… | 1985 |
What descends from it? (2)
2 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 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 37 ancestors has a recall.
- Of its descendants, K213757 (Maruchi, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K082943.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102867: Iroot FS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102867
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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