EKONIC DENTAL/MEDICAL MASK (MD 610)

EKONIC DENTAL/MEDICAL MASK (MD 610) is an FDA 510(k)-cleared medical device (K970440) manufactured by Ekonic Company, Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 1997. Regulation: 8.