FDA 510(k) Application Details - K143071

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K143071
Device Name	Powder, Porcelain
Applicant	DOCERAM MEDICAL CERAMICS GMBH HESSLINGSWEG 65-67 DORTMUND, NRW D-44309 DE Other 510(k) Applications for this Company
Contact	Stefan Drude 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	10/27/2014
Decision Date	06/26/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review