510(k) · Cleared
ClearedVista Clear
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 Mar 4, 2020 as substantially equivalent to K123215 (Ultradent Products, Inc., 2013) after an 89-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Mar 4, 2020
- Review
- 89 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093711 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK093711 RacegelSeptodont · 2010
- 1 generation backK123215 Viscostat ClearUltradent Products, Inc. · 2013
- This deviceK193389 Vista ClearInter-Med/Vista Dental Products · 2020
- Descendant · cites it directly · 0 of its ownK211419 Gingi-Aid GelBelport Company, Inc., Gingi-Pak · 2022
- Descendant · cites it directly · 0 of its ownK200764 StatstixCentrix Incorporated · 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 |
|---|---|---|---|---|---|
| −2 | K093711 | Racegel | Septodont | 2010 | — |
| −1 | K123215 | Viscostat Clear | Ultradent Products, Inc. | 2013 | — |
| 0 (this device) | K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020 | — |
| +1 | K211419 | Gingi-Aid Gel | Belport Company, Inc., Gingi-Pak | 2022 | — |
| +1 | K200764 | Statstix | Centrix Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123215 | Viscostat ClearSummary page 4…etary Name: Vista Clear Common Name: Cord, Retraction Product Code: MVL Device Class: Unclassified 3. Predicate Device ViscoStat Clear (K123215) by Ultradent Products o Common Name: Cord, Retraction o Product Code: MVL o Device Class: Unclassi… | 2013 |
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211419 (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. 2020, 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?
VistaClear 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. VistaClear facilitates 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/K193389 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193389: Vista Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193389
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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