FDA 510(k) Application Details - K152051

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K152051
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Mycone Dental Supply Co., t/a Keystone Industries t/a Keystone Industries, Mizzy & Deepak Products 52 West King Street Myerstown, PA 17067 US Other 510(k) Applications for this Company
Contact	Tracey Schwear 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	07/23/2015
Decision Date	03/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review