# K051409: Slivasure

- Pathway: 510(k) (Traditional)
- Applicant: Scandinavian Formulas, Inc.
- Decided: Aug 8, 2005 after 69 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122663: Oramoist (2013), 0 descendants of its own

## Indications for use
SalivaSure TM promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Syndrome, or because of oral inflammation. Salivasure m provides temporary relief for xerostomia, dry mouth or damaged salivary function. The Ova The Coumter labeling indicates that SalivaSureT is suitable for relief from dry mouth.

Source page: https://510kreport.com/device/K051409
Methodology: https://510kreport.com/methodology