BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS

BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS is an FDA 510(k)-cleared medical device (K894844) manufactured by Straumann Institute, 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 February 1, 1990. Regulation: 8.