ONEPLANT DENTAL IMPLANT SYSTEM

ONEPLANT DENTAL IMPLANT SYSTEM is an FDA 510(k)-cleared medical device (K081748) manufactured by Warantec Co., 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 March 26, 2009. Regulation: 8.