# K152064: Astringedent Clear

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Sep 24, 2015 after 62 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: 2 generations back to K093711 (2010). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123215: Viscostat Clear, Ultradent Products, Inc. (2013) Summary page 5.

## Most influential descendants
- K190220: Vista FS, Vista FS Liquid (2019), 1 descendant of its own
- K211420: Stasis Gel (2022), 0 descendants of its own

## Indications for use
Astringedent 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 solution facilitates the insertion of the cord into the sulcus.

Source page: https://510kreport.com/device/K152064
Methodology: https://510kreport.com/methodology