# K122663: Oramoist

- Pathway: 510(k) (Traditional)
- Applicant: Quantum, Inc.
- Decided: May 30, 2013 after 272 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: 1 generation back to K051409 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051409: Slivasure, Scandinavian Formulas, Inc. (2005) Summary page 1.

## Indications for use
OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist" Patches for Dry Mouth provides temporary relief for dry mouth.

Source page: https://510kreport.com/device/K122663
Methodology: https://510kreport.com/methodology