510(k) · Cleared
ClearedEndorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399
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 May 8, 2007 as substantially equivalent to K992097 (Ultradent Products, Inc., 1999) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- May 8, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992097 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992097 EndorezUltradent Products, Inc. · 1999
- This deviceK071106 Endorez Obturation Kit (with Accelerator), Model 403, Endorez…Ultradent Products, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK211995 Sonendo Filling Material 5CSonendo, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK231387 EndofillLumendo AG · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992097 | Endorez | Ultradent Products, Inc. | 1999 | — |
| 0 (this device) | K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator… | Ultradent Products, Inc. | 2007 | — |
| +1 | K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | 2021 | — |
| +1 | K231387 | Endofill | Lumendo AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K992097 | EndorezSummary page 1…2 Classification Product Code: KIF Legally Marketed Predicate Devices to Which Equivalence is Claimed The predicate device is EndoREZ Dual Cure (K992097 and K042756). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah… | 1999 |
| * | K042756 | EndorezSummary page 1…Classification Product Code: KIF Legally Marketed Predicate Devices to Which Equivalence is Claimed The predicate device is EndoREZ Dual Cure (K992097 and K042756). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. Pr… | 2004 |
What descends from it? (2)
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. 2007, 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?
EndoREZ is designed to be used with EndoREZ Points and/or gutta percha for the filling of cleaned and shaped root canals. EndoREZ, in conjunction with a master cone and accessory cones (as needed), provides optimum sealing. Although EndoREZ Points are recommended, EndoREZ may be used with all conventional endodontic obturation techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071106: Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071106
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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