# K211813: Triton

- Pathway: 510(k) (Special)
- Applicant: Inter-Med / Vista Dental
- Decided: Aug 18, 2021 after 68 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: 6 generations back to K003422 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193357: V-Mix, Inter-Med/Vista Dental Products (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K211813
Methodology: https://510kreport.com/methodology