FDA 510(k) Application Details - K974828

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K974828
Device Name	Implant, Endosseous, Root-Form
Applicant	NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 WESTMONT, IL 60559 US Other 510(k) Applications for this Company
Contact	BETSY A BROWN 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	12/24/1997
Decision Date	03/24/1998
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