FDA 510(k) Application Details - K050641

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K050641
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	ELIZABETH MASON Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2005
Decision Date	04/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review