BII-PORE(TM) CANAL WALL PROSTHESIS

BII-PORE(TM) CANAL WALL PROSTHESIS is an FDA 510(k)-cleared medical device (K934049) manufactured by Bio-Interfaces, 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 July 18, 1994. Regulation: 8.