# K123215: Viscostat Clear

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Feb 5, 2013 after 113 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
Longest line of descent: 1 generation back to K093711 (2010). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093711: Racegel, Septodont (2010) Summary page 1.

## Most influential descendants
- 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
- K211419: Gingi-Aid Gel (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K123215
Methodology: https://510kreport.com/methodology