
Implant Direct Sybron Manufacturing, LLC
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Implant Direct Dental Implant Systems Portfolio - MR Conditional is an FDA 510(k)-cleared medical device (K222211) manufactured by Implant Direct Sybron Manufacturing, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 1, 2023. Regulation: 8.