# K103244: Qmix 2IN1 Endodontic Irrigating Solution

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Feb 14, 2011 after 104 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: 3 generations back to K003422 (2001). 3 ancestors in all.
7 later devices descend from it; 4 cite 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)
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 1.

## Most influential descendants
- K193409: Vista Rinse, Vista Rinse Plus (2020), 2 descendants of its own
- K193357: V-Mix (2020), 1 descendant of its own
- K112250: CHX=CHX Plus (2011), 1 descendant of its own
- K211813: Triton (2021), 0 descendants of its own
- K160577: PacEndo Chlorhexidine (2016), 0 descendants of its own

## Indications for use
QMixTM 2inl Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.

Source page: https://510kreport.com/device/K103244
Methodology: https://510kreport.com/methodology