
W. L. Gore & Associates, Inc.
Free shipping on orders over $99 · 30-day returns
RESOLUT REGENERATIVE MATERIAL is an FDA 510(k)-cleared medical device (K970884) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 1997. Regulation: 8.