SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS

SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS is an FDA 510(k)-cleared medical device (K102308) manufactured by Dentium 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 November 21, 2010. Regulation: 8.