FDA 510(k) Application Details - K153144

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K153144
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	DENTTIO, INC. 3235 N. SAN FERNANDO ROAD BLDG 7B LOS ANGELES, CA 90065 US Other 510(k) Applications for this Company
Contact	YOUNG HAN Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2015
Decision Date	02/10/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review