510(k) K062566

NOBELREPLACE TAPERED CONICAL CONNECTION by Nobel Biocare USA, LLC — Product Code DZE

K062566 is an FDA 510(k) premarket notification submitted by Nobel Biocare USA, LLC for the device "NOBELREPLACE TAPERED CONICAL CONNECTION". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Nobel Biocare USA, LLC has at least 8 other 510(k) clearances on record.