Allday Moisturizing Rinse

Allday Moisturizing Rinse is an oral moisturizing rinse that patients swish in their mouth for 30 seconds then spit out. It is designed to provide relief from dry mouth symptoms including oral malodor, discomfort, and difficulties eating or speaking by coating the inside of the mouth with an artificial saliva formulation.

The chemical composition is nearly identical to the predicate device Elevate Moisturizing Spray, containing water, flavorings, sweeteners, glycerol, and thickening agents. The subject device adds glycolipids for improved mouth feel and sucralose for flavor, with ingredient percentages adjusted to accommodate rinse delivery versus spray delivery of the predicate.

ISO 10993 (biocompatibility assessment) and ISO 14971 (risk assessment) were conducted. A moisture desorption test was performed by incubating 0.4g of product at 37°C for 2 hours and measuring weight loss as a percentage, which is the most common test for LFD product code devices.