CERTAIN BELLATEK PROVISIONAL ABUTMENTS

CERTAIN BELLATEK PROVISIONAL ABUTMENTS is an FDA 510(k)-cleared medical device (K130310) manufactured by Biomet 3i. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2013. Regulation: 8.