# K202689: Dentilube Spray

- Pathway: 510(k) (Traditional)
- Applicant: Oxy2plus, LLC
- Decided: Sep 3, 2021 after 353 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: 7 generations back to K874106 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072306: Bioxtra Moisturizing Gel, Bio-X Healthcare S.A. (2007) Summary page 4.

## Indications for use
Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.

Source page: https://510kreport.com/device/K202689
Methodology: https://510kreport.com/methodology