# K142549: Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste

- Pathway: 510(k) (Traditional)
- Applicant: J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA
- Decided: May 26, 2015 after 258 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: 6 generations back to K874106 (1988). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash, Glaxosmithkline Consumer Healthcare (Gskch) (2010) Summary page 5.

## Most influential descendants
- K240508: Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K142549
Methodology: https://510kreport.com/methodology