
Cosmedent, Inc.
Free shipping on orders over $99 · 30-day returns
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION is an FDA 510(k)-cleared medical device (K921820) manufactured by Cosmedent, 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 June 15, 1992. Regulation: 8.