510(k) · Cleared
ClearedInjectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enpuno Biotechnology Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on May 28, 2024 as substantially equivalent to K212983 (Beijing C-Root Dental Medical Devices Co., Ltd., 2021) after a 116-day review. Its family tree reaches back 8 generations to 1999. 2 later devices descend from it.
- Decided
- May 28, 2024
- Review
- 116 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K990131 (1999). 30 ancestors in all, the oldest K852682 (1985). 2 later devices descend from it, 1 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 backK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
- This deviceK240304 Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR…Enpuno Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK250710 Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253909 NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · 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 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K212983 | Injectable Root Canal Bioceramic SealerSummary page 5…l Specialty: Dental Review Panel: Dental Product Code: KIF Regulation Number: 21 CFR 872.3820 Device Classification: Class II 4. The Predicate Devices Predicate device: K212983 Injectable Root Canal Bioceramic Sealer Beijing C-Root Dental Medical Devices Co., LTD.… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | 2025 | 1 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K250710 (Enpuno Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K212983.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
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/K240304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240304: Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240304
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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