OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL

OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL is an FDA 510(k)-cleared medical device (K944943) manufactured by Opti-Max. 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, 1995. Regulation: 8.