510(k) · Cleared
ClearediRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
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 Nov 22, 2022 as substantially equivalent to K142178 (Dentsply International, Inc., 2015) and 3 other predicates after a 55-day review. Its family tree reaches back 10 generations to 1999.
- Decided
- Nov 22, 2022
- Review
- 55 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K990131 (1999). 42 ancestors in all, the oldest K851606 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 6 generations between
- 3 generations backK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- 2 generations backK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- 1 generation backK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
- This deviceK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 9 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 8 generations backK032268 MBCPBiomatlante · 2003
- 7 generations backK043005 Modification to MBCPBiomatlante · 2005
- 6 generations backK051885 MBCPBiomatlante · 2005
- 5 generations backK060732 MBCP GelBiomatlante · 2006
- 4 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 3 generations backK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- 2 generations backK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- 1 generation backK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
- This deviceK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −9 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −8 | K032268 | MBCP | Biomatlante | 2003 | — |
| −7 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −6 | K051885 | MBCP | Biomatlante | 2005 | — |
| −5 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −4 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −3 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| −2 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| −1 | K102867 | Iroot FS | Innovative Bioceramix, Inc. | 2010 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K142178 | Proroot Mta White, Proroot Mta GraySummary page 4…mber 872.3820 Product Code KIF I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142178 ProRoot MTA KIF K082943 iRoot BP KIF K092715 iRoot BP Plus KIF K102867 iRoot FS KIF Device Description Summary 21 CFR 807.92(a)(4… | 2015 |
| * | K082943 | Iroot BP, Model Irbp 4609Summary page 4…de KIF I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142178 ProRoot MTA KIF K082943 iRoot BP KIF K092715 iRoot BP Plus KIF K102867 iRoot FS KIF Device Description Summary 21 CFR 807.92(a)(4) iRoot BP, iRoot FS, a… | 2009 |
| * | K092715 | Iroot BP PlusSummary page 4…eted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142178 ProRoot MTA KIF K082943 iRoot BP KIF K092715 iRoot BP Plus KIF K102867 iRoot FS KIF Device Description Summary 21 CFR 807.92(a)(4) iRoot BP, iRoot FS, and iRoot BP Plus are… | 2009 |
| * | K102867 | Iroot FSSummary page 4…CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K142178 ProRoot MTA KIF K082943 iRoot BP KIF K092715 iRoot BP Plus KIF K102867 iRoot FS KIF Device Description Summary 21 CFR 807.92(a)(4) iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 42 ancestors has a recall.
- 2 other devices also cite its predicate K142178.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).
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/K222992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222992
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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