OmniTaper EV Dental Implants, DS Implants abutments with EV connection

OmniTaper EV Dental Implants, DS Implants abutments with EV connection is an FDA 510(k)-cleared medical device (K221094) manufactured by Dentsply Sirona. 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 15, 2022. Regulation: 8.