KIS-II IMPLANT SYSTEM/DRILLS

KIS-II IMPLANT SYSTEM/DRILLS is an FDA 510(k)-cleared medical device (K944356) manufactured by Implant Center of the Palm Beaches. 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 4, 1994. Regulation: 8.