
Nobel Biocare AB
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NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM is an FDA 510(k)-cleared medical device (K070857) manufactured by Nobel Biocare AB. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 2007. Regulation: 8.