FDA 510(k) Application Details - K180941

Device Classification Name	More FDA Info for this Device
510(K) Number	K180941
Device Name	Ortho System
Applicant	3Shape A/S Holmens Kanal 7 Copenhagen 1060 DK Other 510(k) Applications for this Company
Contact	Kristian Worziger 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	03/28/2018
Decision Date	10/17/2018
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