OBSIDIAN PRESS (ALL CERAMIC AND POM)

OBSIDIAN PRESS (ALL CERAMIC AND POM) is an FDA 510(k)-cleared medical device (K141887) manufactured by Prismatik Dentalcraft, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 2014. Regulation: 8.