# K041563: Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs

- Pathway: 510(k) (Traditional)
- Applicant: Glaxosmithkline Consumer Healthcare, L.P.
- Decided: Aug 27, 2004 after 78 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: 3 generations back to K874106 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25, Gebauer Co. (2001) Summary page 1.
- K023046: SST Saliva Supporting Tablets, Sinclair Pharmaceuticals, Ltd. (2002) Summary page 1.
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.

## Indications for use
Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of diseases such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. OASIS® mouth moisturizing discs have been formulated for relief of dry mouth symptoms such as'difficutties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Source page: https://510kreport.com/device/K041563
Methodology: https://510kreport.com/methodology