FDA 510(k) Application Details - K160367

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K160367
Device Name	Powder, Porcelain
Applicant	Nissin-Metec China Co., Ltd. No. 883 Beimen Road, Yushan Town Kunshan 215316 CN Other 510(k) Applications for this Company
Contact	Xiwei Shen 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	02/09/2016
Decision Date	07/27/2016
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