FDA 510(k) Application Details - K130662

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K130662
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	03/12/2013
Decision Date	01/10/2014
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