# K253778: Allday Moisturizing Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Elevate Oral Care
- Decided: Feb 27, 2026 after 93 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: 2 generations back to K123731 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150074: Elevate Moisturizing Spray, Elevate Oral Care (2015) Summary page 5.

## Indications for use
Allday Moisturizing Rinse is indicated to provide relief from dry mouth, clean, refresh, and soothe oral tissues. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. Allday Moisturizing Rinse is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath. A mouth rinse that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.

Source page: https://510kreport.com/device/K253778
Methodology: https://510kreport.com/methodology