510(k) · Cleared
ClearedAdseal Root Canal Sealer
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 Nov 24, 2004 as substantially equivalent to K992727 (Mds, 2000) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it.
- Decided
- Nov 24, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960548 (1996). 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- 1 generation backK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- This deviceK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK100248 DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK120048 DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK230010 ADSEAL PlusMeta Biomed Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK202281 EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021
- Descendant · cites it directly · 0 of its ownK132123 TRC-Pex, Radic-SealerKm Corporation · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100248DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010 · cites it directly2descendants
- K120048DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012 · 2 generations on1descendant
- K230010ADSEAL PlusMeta Biomed Co., Ltd. · 2023 · cites it directly0descendants
- K202281EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021 · 2 generations on0descendants
- K132123TRC-Pex, Radic-SealerKm Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| −1 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| 0 (this device) | K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | 2004 | — |
| +1 | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S | Drfp, Ltd. | 2010 | — |
| +2 | K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S | Drfp, Ltd. | 2012 | — |
| +1 | K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023 | — |
| +2 | K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021 | — |
| +1 | K132123 | TRC-Pex, Radic-Sealer | Km Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement SystemSummary page 2…described herein with respect to indications for use, device design, materials, and method of manufacture: Bi-Directional Spiral & Epoxy Root Canal Cement System K992727 Dentsply AH Plus Root Canal Sealer K960548 Dentsply All 26 Root Canal Sealer (Pre- Amendment Device) The predicate d… | 2000 |
| * | K960548 | AH Plus Root Canal SealerSummary page 2…use, device design, materials, and method of manufacture: Bi-Directional Spiral & Epoxy Root Canal Cement System K992727 Dentsply AH Plus Root Canal Sealer K960548 Dentsply All 26 Root Canal Sealer (Pre- Amendment Device) The predicate devices are commercially available and a marketed… | 1996 |
| * | — | Dentsply All 26 Root Canal Sealer (Pre-Amendment Device) Named without a submission number |
What descends from it? (7)
5 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 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K100248 (Drfp, Ltd., 2010) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K992727.
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?
Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used inconjunction with the auxiliary materials in the root canal (i.e. gutta percha points)
Adseal 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/K042769 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042769: Adseal Root Canal Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042769
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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