510(k) · Cleared
ClearedMetapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Oct 7, 2003 as substantially equivalent to K973667 (Neodental Chemical Products Co., Ltd., 1997) after a 43-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Oct 7, 2003
- Review
- 43 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973667 (1997). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK973667 Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 1997
- This deviceK032603 Metapex Calcium Hydroxide with Lodoform Temporary Root Canal FillingMeta Biomed Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK182625 Diapex PlusDiaDent Group International · 2019
- Descendant · 2 generations on · 0 of its ownK202617 Metapex PlusMeta Biomed Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK133716 TRC-PasteKm Corporation · 2014
- Descendant · cites it directly · 0 of its ownK132123 TRC-Pex, Radic-SealerKm Corporation · 2014
- Descendant · cites it directly · 0 of its ownK080266 Well-PexVericom Co., Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K182625Diapex PlusDiaDent Group International · 2019 · cites it directly1descendant
- K202617Metapex PlusMeta Biomed Co., Ltd. · 2021 · 2 generations on0descendants
- K133716TRC-PasteKm Corporation · 2014 · cites it directly0descendants
- K132123TRC-Pex, Radic-SealerKm Corporation · 2014 · cites it directly0descendants
- K080266Well-PexVericom Co., Ltd. · 2008 · cites it directly0descendants
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) | K032603 | Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling | Meta Biomed Co., Ltd. | 2003 | — |
| +1 | K182625 | Diapex Plus | DiaDent Group International | 2019 | — |
| +2 | K202617 | Metapex Plus | Meta Biomed Co., Ltd. | 2021 | — |
| +1 | K133716 | TRC-Paste | Km Corporation | 2014 | — |
| +1 | K132123 | TRC-Pex, Radic-Sealer | Km Corporation | 2014 | — |
| +1 | K080266 | Well-Pex | Vericom Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 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? (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 2…dicate device described herein with respect to indications for use, device design, materials, and method of manufacture: Vitapex Pre-Loaded Dental Syringe - (K973667) The predicate device is commercially available and a marketed Class II device indicated for use as a temporary root canal sealer… | 1997 |
What descends from it? (5)
4 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?
Metapex calcium hydroxide with Iodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate 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…
Read the full statement (161 words)
Metapex calcium hydroxide with Iodoform is a biocompatible temporary or permanent
root canal sealer, for use to stimulate 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 apexificaation, and/or for the tip filling of prepared, treated root
canals at the time of final filling with gutta-percha.
Metapex is intended for use by qualified healthcare personnel trained in its use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032603 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032603: Metapex Calcium Hydroxide with Lodoform Temporary Root Canal Filling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032603
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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