# K071617: Oral Neutralizer

- Pathway: 510(k) (Traditional)
- Applicant: Oral Biotech
- Decided: Oct 19, 2007 after 128 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: 5 generations back to K874106 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061331: Oral Balance Liquid/ Gel, Laclede, Inc. (2006) Summary page 1.
- K991938: Caphosol Artificial Saliva, Inpharma A.S. (1999) Summary page 1.
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25, Gebauer Co. (2001) Summary page 1.
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.
- K051812: Tgo Spray, Laboratoires Carilene S.A.S. (2005) Summary page 1.

## Indications for use
A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostomia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.

Source page: https://510kreport.com/device/K071617
Methodology: https://510kreport.com/methodology