FDA 510(k) Application Details - K150196

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K150196
Device Name	Powder, Porcelain
Applicant	DENTAL DIREKT GMBH INDUSTRIEZENTRUM 106-108 SPENGE 32139 DE Other 510(k) Applications for this Company
Contact	UWE GREITENS 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	01/29/2015
Decision Date	03/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review