
Universal Implant Systems, Inc.
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OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS is an FDA 510(k)-cleared medical device (K905223) manufactured by Universal Implant Systems, 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 15, 1991. Regulation: 8.