SULZER DENTAL CERAMIC SYSTEM-SPLINE

SULZER DENTAL CERAMIC SYSTEM-SPLINE is an FDA 510(k)-cleared medical device (K014214) manufactured by Sulzer Dental, 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 March 18, 2002. Regulation: 8.