# K201277: Oral-B Dry Mouth Oral Rinse

- Pathway: 510(k) (Traditional)
- Applicant: The Procter & Gamble Company
- Decided: Sep 2, 2020 after 112 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181134: G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray, Sunstar Americas, Inc. (2018) Summary page 5.

## Most influential descendants
- K203567: Oral-B Dry Mouth Oral Rinse (2021), 0 descendants of its own

## 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 4 hours.

Source page: https://510kreport.com/device/K201277
Methodology: https://510kreport.com/methodology