510(k) · Cleared
ClearedSonendo Filling Material 5C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonendo, Inc. · KIF Resin, Root Canal Filling
Cleared on Aug 27, 2021 as substantially equivalent to K071106 (Ultradent Products, Inc., 2007) after a 60-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Aug 27, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992097 (1999). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK992097 EndorezUltradent Products, Inc. · 1999
- 1 generation backK071106 Endorez Obturation Kit (with Accelerator), Model 403, Endorez…Ultradent Products, Inc. · 2007
- This deviceK211995 Sonendo Filling Material 5CSonendo, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK231387 EndofillLumendo AG · 2023
Most influential descendants
Showing 1 of 1 · See all- K231387EndofillLumendo AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992097 | Endorez | Ultradent Products, Inc. | 1999 | — |
| −1 | K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator… | Ultradent Products, Inc. | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill)…Summary page 4…0 Device Class: II Product Code: KIF 3. Predicate Device: Primary Predicate: EndoREZ Dual Cure, Ultradent Products, Inc., K071106, Product Code KIF Reference Device: Pulp Canal Sealer EWT, Sybron Dental Specialties… | 2007 |
| † | K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | 2016 |
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 |
|---|---|---|---|
| K231387 | Endofill | 2023 | 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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231387 (Lumendo AG, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071106.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211995: Sonendo Filling Material 5C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211995
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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