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Desktop Metal Receives FDA Marketing Clearance for Flexcera 3D Printed Dentures

05/12/2021 05:07

08:51 AM EDT, 05/12/2021 (MT Newswires) -- Desktop Metal's (DM) Desktop Health has received 510(k) clearance from the US Food and Drug Administration for Flexcera Base, a proprietary resin for use in 3D construction of dental prosthetics.

A 510(k) is a premarket submission made to FDA to demonstrate that a device to be marketed is as safe and effective as an already legally marketed device. The company said dental providers using 3D printers will be able to print up to eight customized Flexcera dentures in less than two hours. The company is expected to launch commercially in the US and Canada by the end of June.

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