OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW is an FDA 510(k)-cleared medical device (K952634) manufactured by Opti-Max. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 1995. Regulation: 8.