# K181194: SmartMouth DryMouth Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Triumph Pharmaceuticals, Inc.
- Decided: Feb 15, 2019 after 287 days
- Product code: LFD (Saliva, Artificial)
- 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 K123731 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 5.
- K163029: Hydris™ Oral Rinse, Biopharm Consult, LLC (2017) Summary page 5.

## Indications for use
Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.

Source page: https://510kreport.com/device/K181194
Methodology: https://510kreport.com/methodology