Formlabs' Premium Teeth Resin gains FDA 510(k) clearance for temporary crowns, bridges

3D dental printing company Formlabs Dental has received 510(k) medical device clearance from the U.S. Food and Drug Administration (FDA) for its Premium Teeth Resin, the company announced in a press release.

The approval governs the company's resin for crowns, inlays, onlays, veneers, and up to seven-unit temporary bridges, according to Formlabs. The resin comprises a nanoceramic biocompatible material that mimics the natural opalescence of teeth and allows users to produce a range of dental appliances using one material. The applications, Formlabs noted, have previously been approved in the European Union.