FDA 510(k) Application Details - K142043

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K142043
Device Name	Powder, Porcelain
Applicant	JENSEN INDUSTRIES, INC. 50 STILLMAN RD. NORTH HAVEN, CT 06473 US Other 510(k) Applications for this Company
Contact	JORDAN SCHRECK 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	07/28/2014
Decision Date	12/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review