Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes is an FDA 510(k)-cleared medical device (K152959) 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 April 13, 2016. Regulation: 8.