510(k) · Cleared
ClearedIroot BP, Model Irbp 4609
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 Jan 6, 2009 as substantially equivalent to K063422 (Innovative Bioceramix, Inc., 2006) and 2 other predicates after a 96-day review. Its family tree reaches back 7 generations to 1999. 12 later devices descend from it.
- Decided
- Jan 6, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K990131 (1999). 31 ancestors in all, the oldest K852682 (1985). 12 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 deviceK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018
- Descendant · cites it directly · 2 of its ownK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK243353 One-Fil PuttyMediclus Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK240365 Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · cites it directly7descendants
- K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018 · cites it directly3descendants
- K102867Iroot FSInnovative Bioceramix, Inc. · 2010 · cites it directly2descendants
- K243353One-Fil PuttyMediclus Co., Ltd. · 2025 · 2 generations on1descendant
- K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd. · 2024 · 2 generations on1descendant
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) | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +1 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +1 | K180185 | Bio-C Repair | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| +1 | K102867 | Iroot FS | Innovative Bioceramix, Inc. | 2010 | — |
| +2 | K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025 | — |
| +2 | K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1993 | 1 | 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 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K063422 | BioaggregateSummary page 1…CLASSIFICATION Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) NAME: PREDICATE DEVICES: * BioAggregate (K063422) Specific chemical compositions: * BioAggregate… | 2006 |
| * | K080917 | Iroot SP | 2008 |
| * | K952614 | Jeltrate Plus Antimicrobial Impr. MaterialSummary page 1…(K063422) * iRoot SP (KO80917) *Jeltrate® PlUSTM Impression Material (K9526 14) *Clearfil T Ceramic Primer (0 96 Delivery system:… | 1996 |
| * | — | Clearfil™ Ceramic Primer Named without a submission number |
What descends from it? (12)
See all 125 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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 31 ancestors has a recall.
- Of its descendants, K092715 (Innovative Bioceramix, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K063422.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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/K082943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082943: Iroot BP, Model Irbp 4609.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082943
Report an extraction error
Are you the manufacturer?
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