FDA 510(k) Application Details - K122124

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K122124
Device Name	Unit, X-Ray, Extraoral With Timer
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	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2012
Decision Date	05/16/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review