
Lang Dental Mfg. Co., Inc.
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MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN is an FDA 510(k)-cleared medical device (K083195) manufactured by Lang Dental Mfg. Co., 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 4, 2009. Regulation: 8.