Ormco Spark Aligner System

Ormco Spark Aligner System is an FDA 510(k)-cleared medical device (K182826) manufactured by Sybron Dental Specialties. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2018. Regulation: 8.