# K231205: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray

- Pathway: 510(k) (Traditional)
- Applicant: Gurunanda, LLC
- Decided: Aug 22, 2023 after 117 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 K123731 (2013). 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)
- K123731: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray, Glaxosmithkline Consumer Healthcare (Gskch) (2013) Summary page 4.

## Indications for use
The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.

Source page: https://510kreport.com/device/K231205
Methodology: https://510kreport.com/methodology