
Astra Tech, Inc.
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ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS is an FDA 510(k)-cleared medical device (K081666) manufactured by Astra Tech, 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 October 6, 2008. Regulation: 8.