Vivos Inc (RDGL)

[SheikhPenny]

By filing the de novo submission, the Company is seeking reclassification of the product to Class II. The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information. If the de novo submission is granted, the device may be immediately marketed in the United States, though the Company would have to secure funding and commercial arrangements before marketing could commence. If the de novo submission is declined, the Company will explore steps toward seeking approval for the device as a Class III medical device.