FDA 510(k) Application Details - K152451

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K152451
Device Name	Powder, Porcelain
Applicant	SHOFU DENTAL CORPORATION 1225 STONE DRIVE SAN MARCOS, CA 92078 US Other 510(k) Applications for this Company
Contact	MAURO MALZYNER 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	08/28/2015
Decision Date	12/11/2015
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