
Bonafix Surgical and Dental Implants
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Bonafix TWO - Dental Implant System is an FDA 510(k)-cleared medical device (K162853) manufactured by Bonafix Surgical and Dental Implants. 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 13, 2017. Regulation: 8.