BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY

BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY is an FDA 510(k)-cleared medical device (K901095) manufactured by Grimm & Norton. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 1990. Regulation: 8.