510(k) · Cleared
ClearedRacegel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Septodont · MVL Cord, Retraction
Cleared on Feb 17, 2010 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 78 days
- Class
- Class U
- Product code
- MVL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK093711 RacegelSeptodont · 2010
- Descendant · cites it directly · 6 of its ownK123215 Viscostat ClearUltradent Products, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK193389 Vista ClearInter-Med/Vista Dental Products · 2020
- Descendant · 2 generations on · 2 of its ownK152064 Astringedent ClearUltradent Products, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK190220 Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK211420 Stasis GelBelport Company, Inc., Gingi-Pak · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123215Viscostat ClearUltradent Products, Inc. · 2013 · cites it directly6descendants
- K193389Vista ClearInter-Med/Vista Dental Products · 2020 · 2 generations on2descendants
- K152064Astringedent ClearUltradent Products, Inc. · 2015 · 2 generations on2descendants
- K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019 · 2 generations on1descendant
- K211420Stasis GelBelport Company, Inc., Gingi-Pak · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093711 | Racegel | Septodont | 2010 | — |
| +1 | K123215 | Viscostat Clear | Ultradent Products, Inc. | 2013 | — |
| +2 | K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020 | — |
| +2 | K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015 | — |
| +2 | K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019 | 1 |
| +3 | K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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?
- Of its descendants, K123215 (Ultradent Products, Inc., 2013) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MVL devicesMVL Cord, Retraction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
RacegelTM is a gel containing aluminium chloride which is intended for sulcus refraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093711 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093711: Racegel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093711
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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