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Nobel Biocare AB
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MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS is an FDA 510(k)-cleared medical device (K061477) 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 August 10, 2006. Regulation: 8.