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Nobel Biocare AB
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PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 is an FDA 510(k)-cleared medical device (K043042) 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 November 17, 2004. Regulation: 8.