# K193389: Vista Clear

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med/Vista Dental Products
- Decided: Mar 4, 2020 after 89 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; 2 cite 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 4.

## Most influential descendants
- K211419: Gingi-Aid Gel (2022), 0 descendants of its own
- K200764: Statstix (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K193389
Methodology: https://510kreport.com/methodology