FDA 510(k) Application Details - K143439

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K143439
Device Name	Powder, Porcelain
Applicant	KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda ku 1000004 JP Other 510(k) Applications for this Company
Contact	Michio Takigawa 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	12/02/2014
Decision Date	02/27/2015
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