# K061331: Oral Balance Liquid/ Gel

- Pathway: 510(k) (Traditional)
- Applicant: Laclede, Inc.
- Decided: Jul 25, 2006 after 74 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: 4 generations back to K874106 (1988). 6 ancestors in all.
13 later devices descend from it; 8 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991938: Caphosol Artificial Saliva, Inpharma A.S. (1999) Summary page 1.
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25, Gebauer Co. (2001) Summary page 1.
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.
- K051812: Tgo Spray, Laboratoires Carilene S.A.S. (2005) Summary page 1.

## Most influential descendants
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash (2010), 6 descendants of its own
- K062653: Mouthkote Oral Moisturizer, Model 50930-098 (2006), 3 descendants of its own
- K111250: Dry Mouth Mouthwash (2012), 2 descendants of its own
- K103745: Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief (2011), 2 descendants of its own
- K072306: Bioxtra Moisturizing Gel (2007), 2 descendants of its own

## Indications for use
A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.

Source page: https://510kreport.com/device/K061331
Methodology: https://510kreport.com/methodology