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510(k) Data Aggregation
K Number
K173808Device Name
Voutia
Manufacturer
Date Cleared
2018-07-27
(224 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Jeffrey Ward Cash, DDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Voutia™ system is indicated to provide relief of dry mouth by coating, and lubricating oral structures thereby relieving the symptoms of xerostomia (dry mouth).
Device Description
Voutia™ is a non-sterile, single person use device for the treatment of xerostomia, consisting of a circuit board controlled pump, a fluid reservoir bottle, and tubing extension that goes from the pump, over a person's ear and transitions to a smaller tube that terminates in the user's oral cavity. The Voutia™ system delivers potable water to the mouth at nine (9) preprogrammed user selectable rates over a defined time, allowing stationary or portable hands free use.
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