# K193409: Vista Rinse, Vista Rinse Plus

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med/Vista Dental Products
- Decided: Sep 9, 2020 after 275 days
- Product code: KJJ (Cleanser, Root Canal)
- 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: 4 generations back to K003422 (2001). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103244: Qmix 2IN1 Endodontic Irrigating Solution, Dentsply Intl., Inc. (2011) Summary page 4.
- K153528: PacEndo EDTA, Pac-Dent International, Inc. (2016) Summary page 4.

## Most influential descendants
- K193357: V-Mix (2020), 1 descendant of its own
- K211813: Triton (2021), 0 descendants of its own

## Indications for use
Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Source page: https://510kreport.com/device/K193409
Methodology: https://510kreport.com/methodology