510(k) · Cleared
ClearedDiapex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · KIF Resin, Root Canal Filling
Cleared on Jan 16, 2004 as substantially equivalent to K973667 (Neodental Chemical Products Co., Ltd., 1997) after a 64-day review. Its family tree reaches back 1 generation to 1997. 38 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973667 (1997). 38 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK973667 Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 1997
- This deviceK033585 DiapexBisco, Inc. · 2004
- Descendant · cites it directly · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 3 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · cites it directly37descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 2 generations on12descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 3 generations on7descendants
- K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973667 | Vitapex Pre-Loaded Dental Syringe | Neodental Chemical Products Co., Ltd. | 1997 | — |
| 0 (this device) | K033585 | Diapex | Bisco, Inc. | 2004 | — |
| +1 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
| +2 | K212983 | Injectable Root Canal Bioceramic Sealer | Beijing C-Root Dental Medical Devices Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 7 | 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 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 |
|---|---|---|---|
| * | K973667 | Vitapex Pre-Loaded Dental SyringeSummary page 1…er 21 CFR 872.3820 Rood Canal Filling Resin 3. Predicate Device: Vitapex Pre-loaded dental syringe from Neo Dental Chemical Products, cleared under K973667 dated 11/6/1997. 4. Description of Application Device: DIAPEX is a yellow radiopaque calcium hydroxide paste with iodoform, u… | 1997 |
What descends from it? (38)
See all 382 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?
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?
1. For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. 2. 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. 3. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the…
Read the full statement (166 words)
1. For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients.
2. 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.
3. 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.
4. For use in the treatment of infected root canals, or following pulpectomy, or for the apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
1. Intracanal Medicament
2. Apexification
3. Periapical Lesions
4. Root Resorption
5. Temporary Root Filling
6. Perforations
7. Underdeveloped pulpless teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033585 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033585: Diapex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033585
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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