
Neocis, Inc.
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Neocis Guidance System (NGS) with Intraoral Fiducial Array is an FDA 510(k)-cleared medical device (K211129) manufactured by Neocis, Inc.. 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 27, 2021. Regulation: 8.