FDA 510(k) Application Details - K152086

Device Classification Name	More FDA Info for this Device
510(K) Number	K152086
Device Name	3Shape Ortho System
Applicant	3Shape A/S Holmens Kanal 7 Copenhagen DK-1060 DK Other 510(k) Applications for this Company
Contact	Hanne Nielsen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2015
Decision Date	04/28/2016
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