BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)

BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) is an FDA 510(k)-cleared medical device (K951937) manufactured by Bio Path. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 1995. Regulation: 8.