HU II / HS II FIXTURE SYSTEM

HU II / HS II FIXTURE SYSTEM is an FDA 510(k)-cleared medical device (K080387) manufactured by Osstem Implant Co., Ltd.. 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 6, 2008. Regulation: 8.