ISOSIT C & B MATERIAL

ISOSIT C & B MATERIAL is an FDA 510(k)-cleared medical device (K810969) manufactured by Bauer, Cheng & 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 4, 1981. Regulation: 8.