510(k) · Cleared
ClearedDiapex Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · KIF Resin, Root Canal Filling
Cleared on Jun 3, 2019 as substantially equivalent to K973667 (Neodental Chemical Products Co., Ltd., 1997) and 1 other predicate after a 252-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jun 3, 2019
- Review
- 252 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973667 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973667 Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 1997
- 1 generation backK032603 Metapex Calcium Hydroxide with Lodoform Temporary Root Canal FillingMeta Biomed Co., Ltd. · 2003
- This deviceK182625 Diapex PlusDiaDent Group International · 2019
- Descendant · cites it directly · 0 of its ownK202617 Metapex PlusMeta Biomed Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202617Metapex PlusMeta Biomed Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973667 | Vitapex Pre-Loaded Dental Syringe | Neodental Chemical Products Co., Ltd. | 1997 | — |
| −1 | K032603 | Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling | Meta Biomed Co., Ltd. | 2003 | — |
| 0 (this device) | K182625 | Diapex Plus | DiaDent Group International | 2019 | — |
| +1 | K202617 | Metapex Plus | Meta Biomed Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 4…KIF Device Class: I Device Name: DIAPEX PLUS 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K973667 K032603 Applicant: gioLEt);ntal Chemical Products Wit Bigiied Co.. Lid. Device Name: Vitapex Metapex Regulation Number: 21 CFR… | 1997 |
| * | K032603 | Metapex Calcium Hydroxide with Lodoform Temporary Root Canal FillingSummary page 4…ice Class: I Device Name: DIAPEX PLUS 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K973667 K032603 Applicant: gioLEt);ntal Chemical Products Wit Bigiied Co.. Lid. Device Name: Vitapex Metapex Regulation Number: 21 CFR 872.3820… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202617 | Metapex Plus | 2021 | 0 |
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 3 companies; a new generation was cleared every 15.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K202617 (Meta Biomed Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K973667.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
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/K182625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182625: Diapex Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182625
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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