FDA 510(k) Application Details - K140074

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K140074
Device Name	Material, Impression
Applicant	HYGEDENT INC 7TH FLOOR,JINGUI BUSINESS BUILDING #982 CONGYUN RD, BAIYUN DISTRICT GUANGZHOU, GUANGDONG 510420 CN Other 510(k) Applications for this Company
Contact	MIKE GU Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2014
Decision Date	05/21/2014
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