510(k) · Cleared
ClearedMetapaste Plus
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 Jun 30, 2021 as substantially equivalent to K032605 (Meta Biomed Co., Ltd., 2003) after a 96-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Jun 30, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944945 (1994). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944945 Pulpdent Calcium Hydroxide PreparationsPulpdent Corp. · 1994
- 1 generation backK032605 Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal…Meta Biomed Co., Ltd. · 2003
- This deviceK210904 Metapaste PlusMeta Biomed Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK261514 Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253167 Any-PasteMediclus Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944945 | Pulpdent Calcium Hydroxide Preparations | Pulpdent Corp. | 1994 | — |
| −1 | K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal Filling | Meta Biomed Co., Ltd. | 2003 | — |
| 0 (this device) | K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021 | — |
| +1 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
| +1 | K253167 | Any-Paste | Mediclus Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K032605 | Metapaste Calcium Hydroxide with Barium Sulfate Temporary Root Canal FillingSummary page 4…: KIF x Panel: Dental x Regulation Number: 21 CFR 872.3820 x Device Class: Class II x Date prepared: 03/15/2021 Predicate Devices: Primary Predicate x K032605, Metapaste by Meta Biomed Co., Ltd. Device Description Metapaste Plus is a water-based calcium hydroxide paste material for root… | 2003 |
What descends from it? (2)
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 27 years and passes through 2 companies; a new generation was cleared every 17.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K261514 (Guilin Kevin Peter Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032605.
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?
Metapaste Plus is a biocompatible root canal filling used for the temporary filling of root canals after endodontic surgery.
Metapaste Plus can be used on its own and for vital pulpotomy in deciduous teeth.
Metapaste Plus is intended for use by qualified healthcare personnel trained in its use.
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/K210904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210904: Metapaste Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210904
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