# K203567: Oral-B Dry Mouth Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: The Procter & Gamble Company
- Decided: Apr 5, 2021 after 119 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: 3 generations back to K123731 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201277: Oral-B Dry Mouth Oral Rinse, The Procter & Gamble Company (2020) Summary page 4.

## Indications for use
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 6 hours.

Source page: https://510kreport.com/device/K203567
Methodology: https://510kreport.com/methodology