FDA 510(k) Application Details - K050258

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K050258
Device Name	Implant, Endosseous, Root-Form
Applicant	NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	HERBERT CRANE Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2005
Decision Date	04/19/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review