510(k) · Cleared
ClearedBio-C Repair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angelus Industria DE Produtos Odontologicos S/A · KIF Resin, Root Canal Filling
Cleared on Aug 31, 2018 as substantially equivalent to K082943 (Innovative Bioceramix, Inc., 2009) after a 220-day review. Its family tree reaches back 8 generations to 1999. 3 later devices descend from it.
- Decided
- Aug 31, 2018
- Review
- 220 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K990131 (1999). 32 ancestors in all, the oldest K852682 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 7 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 6 generations backK032268 MBCPBiomatlante · 2003
- 5 generations backK043005 Modification to MBCPBiomatlante · 2005
- 4 generations backK051885 MBCPBiomatlante · 2005
- 3 generations backK060732 MBCP GelBiomatlante · 2006
- 2 generations backK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- 1 generation backK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- This deviceK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018
- Descendant · cites it directly · 1 of its ownK243353 One-Fil PuttyMediclus Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251884 One-Fil Putty InjectableMediclus Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK201222 Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −7 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −6 | K032268 | MBCP | Biomatlante | 2003 | — |
| −5 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −4 | K051885 | MBCP | Biomatlante | 2005 | — |
| −3 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| −2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| −1 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| 0 (this device) | K180185 | Bio-C Repair | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| +1 | K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025 | — |
| +2 | K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025 | — |
| +1 | K201222 | Bio-C Repair Ion+ | Angelus Industria DE Produtos Odontologicos S/A | 2021 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K082943 | Iroot BP, Model Irbp 4609Summary page 4…KIF Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch Primary Predicate Device: K082943 iRoot BP (Innovative BioCeramix Inc.) Secondary Reference Device: K172701 BIO-C SEALER (Angelus Indústria de… | 2009 |
| † | K172701 | Bio-C Sealer | 2018 |
What descends from it? (3)
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 19 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 32 ancestors has a recall.
- Of its descendants, K243353 (Mediclus Co., Ltd., 2025) has gone furthest, with 1 descendant 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. 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?
Furcation or root perforation treatment via canal;
Furcation or root perforation treatment via surgical;
Internal reabsorption treatment via canal or surgical;
External reabsorption treatment;
Retrofilling in parendodontic surgery;
Direct and indirect pulp capping;
Apexification;
Apexogenesis and Pulpotomy.
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/K180185 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180185: Bio-C Repair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180185
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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