# 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

- Pathway: 510(k) (Traditional)
- Applicant: Sunstar Americas, Inc.
- Decided: Jul 13, 2018 after 74 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
Longest line of descent: 1 generation back to K123731 (2013). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 4.

## Most influential descendants
- K201277: Oral-B Dry Mouth Oral Rinse (2020), 1 descendant of its own
- K203567: Oral-B Dry Mouth Oral Rinse (2021), 0 descendants of its own

## Recalls of this device
- Feb 18, 2021 · Class II · Z-1182-2021: The product may be contaminated with Burkholderia cepacia

## Indications for use
G•U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G•U•M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

Source page: https://510kreport.com/device/K181134
Methodology: https://510kreport.com/methodology