Calcivis Gains PMA Nod for System that Lights Up Tooth Decay

Calcivis has received premarket approval (PMA) from the FDA for an imaging system that allows dentists to visualize decay on patients’ teeth.

The system applies a patented photoprotein that produces a light flash in the presence of free calcium ions that come from an actively decaying tooth surface.

The system features an integrated sensor that detects the light flash and produces a demineralization map which shows early signs of tooth decay.

The PMA program is for Class III devices that undergo FDA review for effectiveness and safety — a higher-risk category that includes approximately 10 percent of medical devices.