510(k) · Cleared
ClearedOne-Fil Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediclus Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Mar 14, 2025 as substantially equivalent to K180185 (Angelus Industria DE Produtos Odontologicos S/A, 2018) after a 136-day review. Its family tree reaches back 9 generations to 1999. 1 later device descends from it.
- Decided
- Mar 14, 2025
- Review
- 136 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K990131 (1999). 33 ancestors in all, the oldest K852682 (1985). 1 later device descends from it, 1 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 backK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018
- This deviceK243353 One-Fil PuttyMediclus Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251884 One-Fil Putty InjectableMediclus Co., Ltd. · 2025
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 backK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018
- This deviceK243353 One-Fil PuttyMediclus Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251884One-Fil Putty InjectableMediclus Co., Ltd. · 2025 · cites it directly0descendants
View 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 | K180185 | Bio-C Repair | Angelus Industria DE Produtos Odontologicos S/A | 2018 | — |
| 0 (this device) | K243353 | One-Fil Putty | Mediclus Co., Ltd. | 2025 | — |
| +1 | K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K180185 | Bio-C RepairSummary page 5…al Filling Classification: Class II, 21 CFR 872.3820 Classification Product Code: KIF 4. Predicate Device: BIO-C REPAIR (K180185) by MEDICLUS Co., Ltd. 1 5. Device Description: One… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251884 | One-Fil Putty Injectable | 2025 | 0 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K251884 (Mediclus Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180185.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K243353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243353: One-Fil Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243353
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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