# K240508: Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)

- Pathway: 510(k) (Traditional)
- Applicant: Laclede, Inc.
- Decided: Apr 19, 2024 after 58 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 5.
- K142549: Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste, J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA (2015) Summary page 5.
- K180680: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray, Laclede, Inc. (2018) Summary page 6.
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 5.

## Indications for use
Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.

Source page: https://510kreport.com/device/K240508
Methodology: https://510kreport.com/methodology