
Nobel Biocare Uas, Inc.
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NOBELRONDO DENTAL CERAMIC-ALUMINA is an FDA 510(k)-cleared medical device (K041312) manufactured by Nobel Biocare Uas, 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 July 22, 2004. Regulation: 8.