510(k) · Cleared
ClearedWell-Root ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vericom Co., Ltd. · KIF Resin, Root Canal Filling
Cleared on Dec 20, 2017 as substantially equivalent to K960548 (Dentsply Intl., 1996) after a 264-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Dec 20, 2017
- Review
- 264 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960548 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- This deviceK170950 Well-Root STVericom Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK232182 One-FilMediclus Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK200175 DIA-ROOT BIO SealerDiaDent Group International · 2020
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 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| 0 (this device) | K170950 | Well-Root ST | Vericom Co., Ltd. | 2017 | — |
| +1 | K232182 | One-Fil | Mediclus Co., Ltd. | 2024 | — |
| +1 | K200175 | DIA-ROOT BIO Sealer | DiaDent Group International | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K960548 | AH Plus Root Canal SealerSummary page 4…tion regulation: 21CFR 872.3820 Product Code: KIF 4. Predicate Device: ▪ Primary Predicate Device: AH PLUS ROOT CANAL SEALER (K960548) by Dentsply International ▪ Reference Device: iRoot SP (K080917) by Innovative BioCeramix, Inc. 5. Descri… | 1996 |
| † | K080917 | Iroot SP | 2008 |
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. 2017, 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?
Permanent sealing of root canal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170950 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170950: Well-Root ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170950
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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