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Nobel Biocare USA, LLC
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NOBELRONDO DENTAL CERAMIC - ZIRCONIA is an FDA 510(k)-cleared medical device (K043312) manufactured by Nobel Biocare USA, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2005. Regulation: 8.