In March 2020, Calcivis received premarket approval from the U.S. Food and Drug Administration to test its system that visualizes enamel demineralization and can help identify carious lesions. The imaging system applies a patented photoprotein that in the presence of free calcium ions released from an actively decaying tooth surface produces a very short, low-level light flash. An integrated intraoral sensor within the device detects the light flash and presents clinicians with a chairside demineralization map.