510(k) · Cleared
ClearedVitapex Pre-Loaded Dental Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neodental Chemical Products Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Nov 6, 1997 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 45 later devices descend from it.
- Decided
- Nov 6, 1997
- Review
- 42 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 4 citing it directly.
- This deviceK973667 Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 1997
- Descendant · cites it directly · 38 of its ownK033585 DiapexBisco, Inc. · 2004
- Descendant · 2 generations on · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · 3 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 4 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K033585DiapexBisco, Inc. · 2004 · cites it directly38descendants
- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · 2 generations on37descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 3 generations on12descendants
- K170175Endoseal MtaMaruchi · 2018 · 3 generations on8descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973667 | Vitapex Pre-Loaded Dental Syringe | Neodental Chemical Products Co., Ltd. | 1997 | — |
| +1 | K033585 | Diapex | Bisco, Inc. | 2004 | — |
| +2 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +3 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +3 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +4 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (45)
See all 454 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?
- Of its descendants, K033585 (Bisco, Inc., 2004) has gone furthest, with 38 descendants of its own.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling…
Read the full statement (137 words)
For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973667: Vitapex Pre-Loaded Dental Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973667
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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