510(k) · Cleared
ClearedAH Plus Root Canal Sealer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KIF Resin, Root Canal Filling
Cleared on Apr 26, 1996 after a 78-day review. The FDA summary names its predicate without a number. 55 later devices descend from it.
- Decided
- Apr 26, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
55 later devices descend from it, 11 citing it directly.
- This deviceK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- Descendant · cites it directly · 37 of its ownK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
- Descendant · 2 generations on · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- Descendant · 2 generations on · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
- Descendant · 3 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K080917Iroot SPInnovative Bioceramix, Inc. · 2008 · cites it directly37descendants
- K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · 2 generations on12descendants
- K992727The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000 · cites it directly9descendants
- K170175Endoseal MtaMaruchi · 2018 · 2 generations on8descendants
- K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| +1 | K080917 | Iroot SP | Innovative Bioceramix, Inc. | 2008 | — |
| +2 | K082943 | Iroot BP, Model Irbp 4609 | Innovative Bioceramix, Inc. | 2009 | — |
| +1 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| +2 | K170175 | Endoseal Mta | Maruchi | 2018 | — |
| +3 | K092715 | Iroot BP Plus | Innovative Bioceramix, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | — | AH26® Root Canal Sealer Named without a submission number |
What descends from it? (55)
See all 5511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080917 | Iroot SP | 2008 | 37 |
| K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | 2000 | 9 |
| K042769 | Adseal Root Canal Sealer | 2004 | 7 |
| K170950 | Well-Root ST | 2017 | 2 |
| K243546 | AH Plus Endodontic Sealer | 2025 | 0 |
| K242702 | VioSeal | 2024 | 0 |
| K182009 | Dia-Proseal | 2019 | 0 |
| K132123 | TRC-Pex, Radic-Sealer | 2014 | 0 |
| K093208 | Simpliseal | 2010 | 0 |
| K063856 | EZ-Fill Xpress Epoxy Root Canal Cement System | 2007 | 0 |
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?
- Of its descendants, K080917 (Innovative Bioceramix, Inc., 2008) has gone furthest, with 37 descendants of its own.
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?
AH® PLUS™ Root Canal Sealer is used 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/K960548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960548: AH Plus Root Canal Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960548
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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