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Dentin Implants Technologies , Ltd.
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DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S is an FDA 510(k)-cleared medical device (K120530) manufactured by Dentin Implants Technologies , Ltd.. 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 4, 2012. Regulation: 8.