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510(k) Data Aggregation
K Number
K071617Device Name
ORAL NEUTRALIZER
Manufacturer
Date Cleared
2007-10-19
(128 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ORAL BIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostemia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.
Device Description
Oral Neutralizer, like the mentioned pre existing devices, is an artificial saliva substitute which, like natural saliva, contains lubricating, neutralizing, and moistening properties to help alleviate the symptoms of dry mouth (xerostomia).
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