FDA 510(k) Application Details - K160498

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K160498
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Dental Solutions, LLC 7701 Golden Valley Road P.O.Box 270725 Golden Valley, MN 55427 US Other 510(k) Applications for this Company
Contact	Kendra Shoulders 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	02/23/2016
Decision Date	06/15/2016
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