510(k) · Cleared
ClearedStasis Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Belport Company, Inc., Gingi-Pak · MVL Cord, Retraction
Cleared on Mar 14, 2022 as substantially equivalent to K190220 (Inter-Med/Vista Dental Products, 2019) after a 311-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Mar 14, 2022
- Review
- 311 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K093711 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK093711 RacegelSeptodont · 2010
- 3 generations backK123215 Viscostat ClearUltradent Products, Inc. · 2013
- 2 generations backK152064 Astringedent ClearUltradent Products, Inc. · 2015
- 1 generation backK190220 Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019 · Recalled
- This deviceK211420 Stasis GelBelport Company, Inc., Gingi-Pak · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093711 | Racegel | Septodont | 2010 | — |
| −3 | K123215 | Viscostat Clear | Ultradent Products, Inc. | 2013 | — |
| −2 | K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015 | — |
| −1 | K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019 | 1 |
| 0 (this device) | K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K190220 | Vista FS, Vista FS LiquidSummary page 4…vice Classification: Unclassified Product Code: MVL III. Predicate Device(s) Predicate Device Trade Vista FS Name: 510 (k) Number: K190220 Submitter: Inter-Med/ Vista Dental Products Device Classification: Unclassified Product Code: MVL… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
STASIS Gel is 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. STASIS Gel facilitates the insertion of the cord into the sulcus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211420 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211420: Stasis Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211420
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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