
Inter-Med, Inc.
Free shipping on orders over $99 · 30-day returns
REGEN Bioactive Cement is an FDA 510(k)-cleared medical device (K253337) manufactured by Inter-Med, 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 April 14, 2026. Regulation: 8.