510(k) · Cleared
ClearedNeoPEX™ Pre-Mixed Obturation Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuSmile, Ltd. · KIF Resin, Root Canal Filling
Cleared on Sep 4, 2026 as substantially equivalent to K250710 (Enpuno Co., Ltd., 2025) after a 270-day review. Its family tree reaches back 10 generations to 1999.
- Decided
- Sep 4, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K990131 (1999). 32 ancestors in all, the oldest K852682 (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 backK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
- 2 generations backK240304 Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR…Enpuno Biotechnology Co., Ltd. · 2024
- 1 generation backK250710 Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd. · 2025
- This deviceK253909 NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd. · 2026
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 backK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
- 2 generations backK240304 Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR…Enpuno Biotechnology Co., Ltd. · 2024
- 1 generation backK250710 Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd. · 2025
- This deviceK253909 NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd. · 2026
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 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
| −2 | K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3… | Enpuno Biotechnology Co., Ltd. | 2024 | — |
| −1 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025 | — |
| 0 (this device) | K253909 | NeoPEX™ Pre-Mixed Obturation Paste | NuSmile, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2004 | 4 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP)Summary page 5…Filling Material Classification Root Canal Filling Material 21 CFR 872.3820 Product Code: KIF, EJK Predicate Devices Primary Predicate • nRoot SP (K250710) Reference Predicate Devices • nRoot BP (K251465) • MTA2.3 Root & Pulp Materials (K181917) • UltraCal XS (K211905) Dev… | 2025 |
| † | K251465 | Root canal repair materials (nRoot BP) | 2025 |
| † | K181917 | MTA2.3 Materials | 2019 |
| † | K211905 | UltraCal XS | 2021 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- None of the 32 ancestors has a recall.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Obturation and sealing of root canals following extirpation and pulpectomy
Vital Pulpotomy
Pulp capping
Repair of Root Resorption
Apexification and/or Perforations
Root canal filling for primary teeth
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/K253909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253909: NeoPEX™ Pre-Mixed Obturation Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253909
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026