510(k) · Cleared
ClearedViscostat Clear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · MVL Cord, Retraction
Cleared on Feb 5, 2013 as substantially equivalent to K093711 (Septodont, 2010) after a 113-day review. Its family tree reaches back 1 generation to 2010. 6 later devices descend from it.
- Decided
- Feb 5, 2013
- Review
- 113 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093711 (2010). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK093711 RacegelSeptodont · 2010
- This deviceK123215 Viscostat ClearUltradent Products, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK193389 Vista ClearInter-Med/Vista Dental Products · 2020
- Descendant · cites it directly · 2 of its ownK152064 Astringedent ClearUltradent Products, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK190220 Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK211420 Stasis GelBelport Company, Inc., Gingi-Pak · 2022
- Descendant · 2 generations on · 0 of its ownK211419 Gingi-Aid GelBelport Company, Inc., Gingi-Pak · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193389Vista ClearInter-Med/Vista Dental Products · 2020 · cites it directly2descendants
- K152064Astringedent ClearUltradent Products, Inc. · 2015 · cites it directly2descendants
- K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019 · cites it directly1descendant
- K211420Stasis GelBelport Company, Inc., Gingi-Pak · 2022 · 2 generations on0descendants
- K211419Gingi-Aid GelBelport Company, Inc., Gingi-Pak · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093711 | Racegel | Septodont | 2010 | — |
| 0 (this device) | K123215 | Viscostat Clear | Ultradent Products, Inc. | 2013 | — |
| +1 | K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020 | — |
| +1 | K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015 | — |
| +1 | K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019 | 1 |
| +2 | K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022 | — |
| +2 | K211419 | Gingi-Aid Gel | Belport Company, Inc., Gingi-Pak | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K093711 | RacegelSummary page 1…n No. None Ill. Legally Marketed Predicate Devices to Which Equivalence is Claimed ViscoStat" Clear is substantially equivalent to Racege TM (K093711), manufactured by Septodont, which is cleared under dental device product code MVL (cord; retraction). Viscotat Clear is substant… | 2010 |
What descends from it? (6)
3 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 MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Viscotat Clear 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 and/or the Dento Infusor. The gel facilitates the insertion of the cord into the sulcus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123215: Viscostat Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123215
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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