HEXIM Implant; Samwon General Abutments

HEXIM Implant; Samwon General Abutments is an FDA 510(k)-cleared medical device (K243731) manufactured by P&A USA. 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 8, 2025. Regulation: 8.