510(k) · Cleared
ClearedInjectable Root Canal Bioceramic Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing C-Root Dental Medical Devices Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Dec 8, 2021 as substantially equivalent to K080917 (Innovative Bioceramix, Inc., 2008) after an 82-day review. Its family tree reaches back 7 generations to 1999. 4 later devices descend from it.
- Decided
- Dec 8, 2021
- Review
- 82 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K990131 (1999). 29 ancestors in all, the oldest K852682 (1985). 4 later devices descend from it, 2 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 deviceK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK240304 Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR…Enpuno Biotechnology Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250710 Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK253909 NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK241977 Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd. · 2024 · cites it directly2descendants
- K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd. · 2025 · 2 generations on1descendant
- K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd. · 2026 · 3 generations on0descendants
- K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd. · 2024 · cites it directly0descendants
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) | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
| +1 | K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3… | Enpuno Biotechnology Co., Ltd. | 2024 | — |
| +2 | K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | 2025 | — |
| +3 | K253909 | NeoPEX™ Pre-Mixed Obturation Paste | NuSmile, Ltd. | 2026 | — |
| +1 | K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K080917 | Iroot SPSummary page 4…ber: 21 CFR 872.3820 Classification: Class II Panel: Dental 4.0 Identification of Predicate Device and Reference Device Predicate Device: 510(k) Number: K080917 Product Name: iRoot SP 1 of page 6 510(k) Summary Manufacturer: Innovative B… | 2008 |
What descends from it? (4)
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 22 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K240304 (Enpuno Biotechnology Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K080917.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 pulpextirpation.
* Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
C-Root SP 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/K212983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212983: Injectable Root Canal Bioceramic Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212983
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