ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE

ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE is an FDA 510(k)-cleared medical device (K063734) manufactured by Atlantis Components, 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 March 1, 2007. Regulation: 8.