BEL-CYPHER, MODEL Y977

BEL-CYPHER, MODEL Y977 is an FDA 510(k)-cleared medical device (K090020) manufactured by Takara-Belmont Co., Ltd.. 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 12, 2009. Regulation: 8.