Search Results
Found 1 results
510(k) Data Aggregation
K Number
K163476Device Name
Lubricity
Manufacturer
Date Cleared
2017-05-10
(149 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
You First Services, Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity.
Device Description
Lubricity® is an oral saliva substitute containing gel film forming polysaccharides, Sodium Hyaluronate, which has lubricating and moisturizing properties in the buccal cavity. The product is formulated, preserved and packed in blow molded polyethylene terephthalate bottles with a closure system comprising a metered dose liquid spray fitting manufactured from polypropylene, high density polyethylene, polymethoxylene copolymer and stainless steel (spring). All container closure components have appropriate status under FDA food contact or GRAS regulations.
Ask a Question
Ask a specific question about this device
Page 1 of 1