Search Results

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.

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).

The provided document is a 510(k) premarket notification for the Oral BioTech Oral Neutralizer, an artificial saliva substitute. It asserts substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), training set information, and ground truth establishment is not available in the provided text.

The document states:

• "Functional and performance evaluation has been conducted to assess the safety and effectiveness of Oral Neutralizer liquid, gel, and spray. All results are satisfactory." This is a very general statement and does not provide any specific criteria, methods, or results of such evaluation.

The primary mechanism for approval in this 510(k) submission is the demonstration of substantial equivalence to predicate devices already on the market, not a direct performance study against specific acceptance criteria. The detailed study information requested is typically associated with clinical trials or more rigorous performance testing for novel devices or those seeking a higher level of evidence.

Ask a specific question about this device