510(k) · Cleared
ClearedPulp Canal Sealer, Pulp Canal Sealer EWT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties · KIF Resin, Root Canal Filling
Cleared on May 6, 2016 as substantially equivalent to K945244 (Sybron Dental Specialties, Inc., 1994) after a 212-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- May 6, 2016
- Review
- 212 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945244 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK945244 Pulp Canal Sealer EwtSybron Dental Specialties, Inc. · 1994
- This deviceK152956 Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties · 2016
- Descendant · cites it directly · 0 of its ownK212563 CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra…Prevest Denpro Limited · 2022
Most influential descendants
Showing 1 of 1 · See all- K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945244 | Pulp Canal Sealer Ewt | Sybron Dental Specialties, Inc. | 1994 | — |
| 0 (this device) | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | Sybron Dental Specialties | 2016 | — |
| +1 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical… | Prevest Denpro Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K945244 | Pulp Canal Sealer EwtSummary page 4…Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the legally marketed device Pulp Canal Sealer/Pulp Canal Sealer EWT (K945244) cleared on December 29, 1994, product code KIF. 4. Description of Device: Pulp Can… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra… | 2022 | 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?
- Its one ancestor has no recall.
- Of its descendants, K212563 (Prevest Denpro Limited, 2022) has gone furthest, with 0 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. 2016, 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?
Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.
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/K152956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152956: Pulp Canal Sealer, Pulp Canal Sealer EWT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152956
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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