FDA 510(k) Application Details - K984536

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K984536
Device Name	Implant, Endosseous, Root-Form
Applicant	SULZER CALCITEK, INC. 2320 FARADAY AVE. CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	FOSTER BOOP 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	12/21/1998
Decision Date	06/16/1999
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