FDA 510(k) Application Details - K100245

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K100245
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. FAIRLESS HILLS, PA 19030 US Other 510(k) Applications for this Company
Contact	PATRICK LIM 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	01/27/2010
Decision Date	08/17/2010
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