COPRA TEMP PMMA-DISK

COPRA TEMP PMMA-DISK is an FDA 510(k)-cleared medical device (K131664) manufactured by White Peaks Dental Systems GmbH & Co. KG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2013. Regulation: 8.