# K072306: Bioxtra Moisturizing Gel

- Pathway: 510(k) (Traditional)
- Applicant: Bio-X Healthcare S.A.
- Decided: Nov 15, 2007 after 90 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.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062653: Mouthkote Oral Moisturizer, Model 50930-098, Parnell Pharmaceuticals, Inc. (2006) Summary page 1.
- K061331: Oral Balance Liquid/ Gel, Laclede, Inc. (2006) 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.
- K030802: Caphosol, Inpharma A.S. (2003) Summary page 1.
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.

## Most influential descendants
- K202689: Dentilube Spray (2021), 0 descendants of its own
- K101346: GC Oral Moisturizing Gel (2011), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sj6gren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel. BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Source page: https://510kreport.com/device/K072306
Methodology: https://510kreport.com/methodology