ZMAXX Dental Zirconia Blanks

ZMAXX Dental Zirconia Blanks is an FDA 510(k)-cleared medical device (K191631) manufactured by Zmaxx Bioceramics, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 2019. Regulation: 8.