# K142657: Xerostom Saliva Substitute Gel

- Pathway: 510(k) (Traditional)
- Applicant: Bio Cosmetics, S.L.
- Decided: Sep 14, 2015 after 361 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth.

Source page: https://510kreport.com/device/K142657
Methodology: https://510kreport.com/methodology