SOPIX INSIDE, SOPIX2 INSIDE

SOPIX INSIDE, SOPIX2 INSIDE is an FDA 510(k)-cleared medical device (K140013) manufactured by Sopro - Acteon Group. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 2014. Regulation: 8.