FDA 510(k) Application Details - K171167

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K171167
Device Name	Powder, Porcelain
Applicant	OperArt LLC 1551 Ocean Ave., Suite 220 Santa Monica, CA 90401 US Other 510(k) Applications for this Company
Contact	Domenico Cascione 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	04/21/2017
Decision Date	12/13/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review