FDA 510(k) Application Details - K153590

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K153590
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Global Dental Science 15730 N 83rd Way, Suite 101 Scottsdale, AZ 85260 US Other 510(k) Applications for this Company
Contact	Chuck Johnson 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	12/16/2015
Decision Date	04/22/2016
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