
Dentsply Implant
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ATLANTIS STRAUMANN BONE LEVEL ABUTMENT is an FDA 510(k)-cleared medical device (K130216) manufactured by Dentsply Implant. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2013. Regulation: 8.