FDA 510(k) Application Details - K151455

Device Classification Name	More FDA Info for this Device
510(K) Number	K151455
Device Name	3Shape Abutment Designer Software
Applicant	3Shape A/S Holemens Kanal 7 Copenhagen 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	PNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2015
Decision Date	09/06/2016
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