VITALA PORCINE DERIVED COLLAGEN MEMBRANE

VITALA PORCINE DERIVED COLLAGEN MEMBRANE is an FDA 510(k)-cleared medical device (K141177) manufactured by Osteogenics Biomedical, Inc. (Formerly Obi Biologi. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2015. Regulation: 8.