
Steri-Oss, Inc.
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REPLACE HA COATED IMPLANTS is an FDA 510(k)-cleared medical device (K962845) manufactured by Steri-Oss, 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 October 17, 1996. Regulation: 8.