510(k) · Cleared
Recalled · Class II · 2026Vista FS, Vista FS Liquid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med/Vista Dental Products · MVL Cord, Retraction
Cleared on Jun 10, 2019 as substantially equivalent to K123215 (Ultradent Products, Inc., 2013) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 10, 2019
- Review
- 125 days
- Class
- Class U
- Product code
- MVL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K093711 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK093711 RacegelSeptodont · 2010
- 2 generations backK123215 Viscostat ClearUltradent Products, Inc. · 2013
- 1 generation backK152064 Astringedent ClearUltradent Products, Inc. · 2015
- This deviceK190220 Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019
- Descendant · cites it directly · 0 of its ownK211420 Stasis GelBelport Company, Inc., Gingi-Pak · 2022
Most influential descendants
Showing 1 of 1 · See all- K211420Stasis GelBelport Company, Inc., Gingi-Pak · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K093711 | Racegel | Septodont | 2010 | — |
| −2 | K123215 | Viscostat Clear | Ultradent Products, Inc. | 2013 | — |
| −1 | K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015 | — |
| 0 (this device) | K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019 | — |
| +1 | K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 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 MVL? 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 MVL device
- #1 K254239 CyClean Cordscore 11.4 · 2 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 |
|---|---|---|---|
| * | K123215 | Viscostat ClearSummary page 4…ta FS and Vista FS Liquid Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified 3. Primary Predicate Device ViscoStat Clear (K123215) by Ultradent Products o Common Name: Cord, Retraction o Product Code: MVL o Device Class: Unclassified… | 2013 |
| * | K152064 | Astringedent ClearSummary page 4…ucts o Common Name: Cord, Retraction o Product Code: MVL o Device Class: Unclassified Additional Predicate Device Astringedent Clear (K152064) by Ultradent Products o Common Name: Cord, Retraction o Product Code: MVL o Device Class: Unclassified… | 2015 |
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 |
|---|---|---|---|
| K211420 | Stasis Gel | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2026 | Class II | Z-2400-2026 | Labeling mix-ups | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211420 (Belport Company, Inc., Gingi-Pak, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123215.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MVL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MVL
227in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVL
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVL
1in 2025
MAUDE reports naming product code MVL, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 91 | 0 | 1 |
| 2010 | 4 | 79 | 0 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 7 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 4 | 227 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Vista FS and Vista FS Liquid are intended for sulcus retraction prior to impression making and to control bleeding and
gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista FS and Vista FS Liquid
facilitate the insertion of the cord into the sulcus.
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/K190220 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190220: Vista FS, Vista FS Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190220
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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