FDA 510(k) Application Details - K051576

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K051576
Device Name	Implant, Endosseous, Root-Form
Applicant	OSSTEM CO., LTD. 27001 LA PAZ ROAD, SUITE #312 MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	ALBERT REGO 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	06/14/2005
Decision Date	09/01/2005
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