
Nobel Biocare AB
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MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS is an FDA 510(k)-cleared medical device (K093643) 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 June 23, 2010. Regulation: 8.