PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM

PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K013798) manufactured by Institut Straumann AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2001. Regulation: 8.