FDA 510(k) Application Details - K141162

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K141162
Device Name	Powder, Porcelain
Applicant	RIZHAO HUGE DENTAL INDUSTRY CO., LTD ROOM 302, NO. 21 BLDG, KAIYU GARDEN, XISHAN SOUTH ROAD WENZHOU, ZHEJIANG 325000 CN Other 510(k) Applications for this Company
Contact	HELEN NAN Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2014
Decision Date	08/27/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review