# K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray

- Pathway: 510(k) (Special)
- Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
- Decided: Jan 4, 2013 after 30 days
- Product code: LFD (Saliva, Artificial)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 9 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181134: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray (2018), 2 descendants of its own
- K163029: Hydris™ Oral Rinse (2017), 2 descendants of its own
- K201277: Oral-B Dry Mouth Oral Rinse (2020), 1 descendant of its own
- K152201: MedActive Oral Gel and Spray (2015), 1 descendant of its own
- K150074: Elevate Moisturizing Spray (2015), 1 descendant of its own

## Recalls of this device
- Oct 17, 2013 · Class II · Z-0272-2014: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

## Indications for use
The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of day mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Source page: https://510kreport.com/device/K123731
Methodology: https://510kreport.com/methodology