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SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Synolome, or because of orar real inflammation. SalivaSure™ provides temporary relief from dry mouth caused by reduced or damaged salivary function.

The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Salivasure." This document does not contain information about acceptance criteria or specific study results proving the device meets acceptance criteria.

The 510(k) letter states that the FDA has reviewed the premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that the FDA has found Salivasure to be as safe and effective as a device already on the market.

Therefore, I cannot provide the requested information from the given text.

The document details:

• Device Name: Salivasure
• 510(k) Number: K051409
• Indications for Use: Promotes lubrication of oral mucosa that may be dry due to side effects of medication, chemotherapy, radiotherapy, or as a symptom of Sjogren's Syndrome, or because of oral inflammation or damaged salivary function. It provides temporary relief from dry mouth.
• Regulatory Class: Unclassified
• Product Code: LED
• Regulation Number: NONE

To answer your request, I would need a different type of document, such as a clinical study report or a detailed summary of safety and performance data submitted with the 510(k) application (which is typically a much larger document than what is provided here).

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