# K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25

- Pathway: 510(k) (Traditional)
- Applicant: Gebauer Co.
- Decided: Aug 6, 2001 after 1,181 days
- Product code: LFD (Saliva, Artificial)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 8 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MOI-STIR® Mouth Moistener: named in the summary without a submission number

## Most influential descendants
- K024148: Salinum, Orclair (2003), 19 descendants of its own
- K051812: Tgo Spray (2005), 16 descendants of its own
- K061331: Oral Balance Liquid/ Gel (2006), 13 descendants of its own
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash (2010), 6 descendants of its own
- K062653: Mouthkote Oral Moisturizer, Model 50930-098 (2006), 3 descendants of its own

## Recalls of this device
- Jan 19, 2007 · Not classified · Z-0497-2007: Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
- Feb 23, 2004 · Not classified · Z-0641-04: The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.

## Indications for use
An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

Source page: https://510kreport.com/device/K981693
Methodology: https://510kreport.com/methodology