# K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash

- Pathway: 510(k) (Traditional)
- Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
- Decided: Sep 28, 2010 after 123 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: 5 generations back to K874106 (1988). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061331: Oral Balance Liquid/ Gel, Laclede, Inc. (2006) Summary page 1.

## Most influential descendants
- K111250: Dry Mouth Mouthwash (2012), 2 descendants of its own
- K180680: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (2018), 1 descendant of its own
- K142549: Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste (2015), 1 descendant of its own
- K240508: Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (2024), 0 descendants of its own
- 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

## Indications for use
Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.

Source page: https://510kreport.com/device/K101477
Methodology: https://510kreport.com/methodology