510(k) K090630

NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) by Nobel Biocare AB — Product Code FZE

K090630 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)". The FDA issued a decision of Substantially Equivalent on June 2, 2009. The device falls under product code FZE (Prosthesis, Nose, Internal), a Class II device regulated under 21 CFR 878.3680. Nobel Biocare AB has at least 10 other 510(k) clearances on record.