510(k) · Cleared
ClearedThe BI-Directional Spiral & Epoxy Root Canal Cement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mds · KIF Resin, Root Canal Filling
Cleared on Jan 18, 2000 as substantially equivalent to K960548 (Dentsply Intl., 1996) after a 158-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Jan 18, 2000
- Review
- 158 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960548 (1996). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- This deviceK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- Descendant · cites it directly · 7 of its ownK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK100248 DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK120048 DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK230010 ADSEAL PlusMeta Biomed Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK202281 EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K042769Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004 · cites it directly7descendants
- K100248DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010 · 2 generations on2descendants
- K120048DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012 · 3 generations on1descendant
- K230010ADSEAL PlusMeta Biomed Co., Ltd. · 2023 · 2 generations on0descendants
- K202281EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| 0 (this device) | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| +1 | 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 | — |
| +3 | K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S | Drfp, Ltd. | 2012 | — |
| +2 | K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023 | — |
| +3 | K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K960548 | AH Plus Root Canal SealerSummary page 1…Directional Spiral & Epoxy Root Canal Cement System Predicate Device Information: 1. AH-26® Root Canal Sealer (Pre-Amendment Device) 2. AH® PLUS® Root Canal Sealer, K# 960548, Dentsply International, York, PA Device Description: The subject device is an obturation system for filling straight and minim… | 1996 |
| * | — | AH-26® Root Canal Sealer Named without a submission number |
What descends from it? (9)
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?
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?
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
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/K992727 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992727: The BI-Directional Spiral & Epoxy Root Canal Cement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992727
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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