
Mds
Free shipping on orders over $99 · 30-day returns
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM is an FDA 510(k)-cleared medical device (K992727) manufactured by Mds. 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 17, 2000. Regulation: 8.