FDA 510(k) Application Details - K111383

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K111383
Device Name	Powder, Porcelain
Applicant	NORITAKE CO., INC. 700 12 STREET, N.W., SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	IVAN WASSERMAN 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	05/17/2011
Decision Date	08/12/2011
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