# K023046: SST Saliva Supporting Tablets

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Dec 2, 2002 after 81 days
- Product code: LED (Stains, Chemical Solution)
- Device class: 1
- Regulation: 21 CFR 864.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874106 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K991938: Caphosol Artificial Saliva, Inpharma A.S. (1999) Summary page 1.

## Most influential descendants
- K041563: Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs (2004), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, SINCLAIR SSTTM promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SSTTM provides temporary relief for damaged salivary function. Over the counter labeling stipulates that SINCLAIR SSTTM is suitable for temporary relief of dry mouth symptoms.

Source page: https://510kreport.com/device/K023046
Methodology: https://510kreport.com/methodology