
Foremost Dental Mfg., Inc.
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ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) is an FDA 510(k)-cleared medical device (K982201) manufactured by Foremost Dental Mfg., 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 August 9, 1998. Regulation: 8.