# K193357: V-Mix

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med/Vista Dental Products
- Decided: Oct 23, 2020 after 324 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: 5 generations back to K003422 (2001). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra, Inter-Med, Inc. (2009) Summary page 4.
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 4.
- K193409: Vista Rinse, Vista Rinse Plus, Inter-Med/Vista Dental Products (2020). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K211813: Triton (2021), 0 descendants of its own

## Indications for use
V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.

Source page: https://510kreport.com/device/K193357
Methodology: https://510kreport.com/methodology