FDA 510(k) Application Details - K131117

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K131117
Device Name	Powder, Porcelain
Applicant	KUWOTECH CO., LTD 1515 E KATELLA AVE UNIT 2115 ANAHEIM, CA 92805 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	04/22/2013
Decision Date	07/26/2013
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