# K101346: GC Oral Moisturizing Gel

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 27, 2011 after 259 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: 7 generations back to K874106 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072306: Bioxtra Moisturizing Gel, Bio-X Healthcare S.A. (2007) Summary page 1.
- K061331: Oral Balance Liquid/ Gel, Laclede, Inc. (2006) Summary page 1.

## Indications for use
GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth.

Source page: https://510kreport.com/device/K101346
Methodology: https://510kreport.com/methodology