ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT

ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT is an FDA 510(k)-cleared medical device (K002374) manufactured by Straumann USA. 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 31, 2000. Regulation: 8.