
Radiant Express, LLC
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ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS is an FDA 510(k)-cleared medical device (K101068) manufactured by Radiant Express, 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 August 22, 2010. Regulation: 8.