FDA 510(k) Application Details - K103105

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K103105
Device Name	Implant, Endosseous, Orthodontic
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	872.3640   More FDA Info for this Regulation Number
Classification Product Code	OAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2010
Decision Date	03/25/2011
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