FDA 510(k) Application Details - K183408

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K183408
Device Name	Powder, Porcelain
Applicant	Jensen Industries, Inc. 50 Stillman Road 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	12/10/2018
Decision Date	03/20/2019
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