FDA 510(k) Application Details - K153253

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K153253
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	GC AMERICA, INC. 3737 W. 127TH ST. ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	MARK HEISS 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	11/10/2015
Decision Date	03/03/2016
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