# K111250: Dry Mouth Mouthwash

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Fresh, Inc.
- Decided: Apr 27, 2012 after 359 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: 6 generations back to K874106 (1988). 8 ancestors in all.
2 later devices descend from it; 2 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)
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash, Glaxosmithkline Consumer Healthcare (Gskch) (2010) Summary page 1.

## Most influential descendants
- K173237: Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist (2018), 0 descendants of its own
- K171542: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges (2018), 0 descendants of its own

## Indications for use
Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness;

Source page: https://510kreport.com/device/K111250
Methodology: https://510kreport.com/methodology