# K091718: Neutrasal

- Pathway: 510(k) (Traditional)
- Applicant: Bartor Pharmacal Co., Inc.
- Decided: Sep 2, 2009 after 83 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 K874106 (1988). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030802: Caphosol, Inpharma A.S. (2003) Summary page 1.
- K991938: Caphosol Artificial Saliva, Inpharma A.S. (1999) Summary page 1.

## Most influential descendants
- K093642: Neutrasal (2009), 1 descendant of its own
- K152406: SalivaMAX (2015), 0 descendants of its own

## Indications for use
(OTC): Neutrasai® is indicated for the dryness of the mouth (hyposalivation, xerostomia) (OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion. (OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity. (Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain. (Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction ofthe salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjbgren's syndrome

Source page: https://510kreport.com/device/K091718
Methodology: https://510kreport.com/methodology