FDA 510(k) Application Details - K162572

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K162572
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	VERTEX-DENTAL BV JOHAN VAN OLDENBARNEVELTLAAN 62 ZEIST 3705 HJ NL Other 510(k) Applications for this Company
Contact	O. F. Beckeringh van Loenen Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2016
Decision Date	06/30/2017
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