# K093711: Racegel

- Pathway: 510(k) (Traditional)
- Applicant: Septodont
- Decided: Feb 17, 2010 after 78 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K123215: Viscostat Clear (2013), 6 descendants of its own
- K193389: Vista Clear (2020), 2 descendants of its own
- K152064: Astringedent Clear (2015), 2 descendants of its own
- K190220: Vista FS, Vista FS Liquid (2019), 1 descendant of its own
- K211420: Stasis Gel (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K093711
Methodology: https://510kreport.com/methodology