The Vigidental application is a Class I medical device. In our analysis and assessment of the risks associated with the use of Vigidental by a patient, we found that the risk was very low, given the field covered: oral hygiene, and the fact that immediate therapeutic treatment is not required. In this sense, Vigidental may well meet the definition of a medical device for which the FDA intends to exercise its enforcement discretion because it presents a lower risk to the public.

There are no known contraindications to the use of the Vigidental application.

The Vigidental app’s technology operates in an open circuit, meaning that the solution will not implement any preventive medical action without prior human intervention.