STER-MATE STERILE LAVAGE KIT

STER-MATE STERILE LAVAGE KIT is an FDA 510(k)-cleared medical device (K082973) manufactured by Dentsply Interntional. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2009. Regulation: 8.