
Nobel Biocare USA, LLC
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ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 is an FDA 510(k)-cleared medical device (K052885) 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 December 22, 2005. Regulation: 8.