510(k) · Cleared
ClearedEDS Bioceramic Sealer (Bioseal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essential Dental Systems · KIF Resin, Root Canal Filling
Cleared on Feb 12, 2021 as substantially equivalent to K120048 (Drfp, Ltd., 2012) and 1 other predicate after a 184-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Feb 12, 2021
- Review
- 184 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960548 (1996). No later device cites it as a predicate yet.
- Root · 5 generations backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- 4 generations backK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- 3 generations backK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- 2 generations backK100248 DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010
- 1 generation backK120048 DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012
- This deviceK202281 EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| −4 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| −3 | K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | 2004 | — |
| −2 | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S | Drfp, Ltd. | 2010 | — |
| −1 | K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S | Drfp, Ltd. | 2012 | — |
| 0 (this device) | K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021 | — |
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 |
|---|---|---|---|
| * | K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SSummary page 4…Device Manufacturer 510K number 1. EndoSequence BC Sealer Brasseler K120048 2. ProSmart Root Canal Obturation System DRFP K100248 4. Device Description:… | 2012 |
| * | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SSummary page 4…BC Sealer Brasseler K120048 2. ProSmart Root Canal Obturation System DRFP K100248 4. Device Description: [807.92 (a)(4)] EDS Bioceramic sealer (Bioseal) is a ready-to-use injectable bioceramic cement… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
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?
Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Suitable for use in single cone and lateral condensation technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202281: EDS Bioceramic Sealer (Bioseal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202281
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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