FDA 510(k) Application Details - K152383

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K152383
Device Name	Powder, Porcelain
Applicant	Emergo Europe Consulting PRINSESSEGRACHT 20 THE HAGUE 2514AP NL Other 510(k) Applications for this Company
Contact	RACHEL PAUL 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	08/24/2015
Decision Date	09/21/2015
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	Y
Expedited Review