510(k) · Cleared
ClearedEndorez
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · KIF Resin, Root Canal Filling
Cleared on Oct 26, 1999 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Oct 26, 1999
- Review
- 127 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK992097 EndorezUltradent Products, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK071106 Endorez Obturation Kit (with Accelerator), Model 403, Endorez…Ultradent Products, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK011748 First Fill R.C.S.Jeneric/Pentron, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK211995 Sonendo Filling Material 5CSonendo, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK231387 EndofillLumendo AG · 2023
- Descendant · 2 generations on · 0 of its ownK060889 SE Epiphany Root Canal Sealant, Model N59SEPentron Clinical Technologies · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071106Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill)…Ultradent Products, Inc. · 2007 · cites it directly2descendants
- K011748First Fill R.C.S.Jeneric/Pentron, Inc. · 2001 · cites it directly2descendants
- K211995Sonendo Filling Material 5CSonendo, Inc. · 2021 · 2 generations on1descendant
- K231387EndofillLumendo AG · 2023 · 2 generations on0descendants
- K060889SE Epiphany Root Canal Sealant, Model N59SEPentron Clinical Technologies · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992097 | Endorez | Ultradent Products, Inc. | 1999 | — |
| +1 | K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator… | Ultradent Products, Inc. | 2007 | — |
| +1 | K011748 | First Fill R.C.S. | Jeneric/Pentron, Inc. | 2001 | — |
| +2 | K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | 2021 | — |
| +2 | K231387 | Endofill | Lumendo AG | 2023 | — |
| +2 | K060889 | SE Epiphany Root Canal Sealant, Model N59SE | Pentron Clinical Technologies | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
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?
- Of its descendants, K071106 (Ultradent Products, Inc., 2007) has gone furthest, with 2 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?
EndoREZ is used for permanent obturation of root canals of teeth of the secondary dentition with or without the aid of obturation points. It is easily delivered to the canals with a small Endo-Eze tip. When mixed and delivered in a syringe, the sealer can be placed close to the apex of the root, eliminating or minimizing air entrapment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992097: Endorez.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992097
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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