FDA 510(k) Application Details - K161884

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K161884
Device Name	Mouthguard, Prescription
Applicant	3Shape A/S Holmens Kanal 7 Copenhagen 1060 DK Other 510(k) Applications for this Company
Contact	Hanne Nielsen Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2016
Decision Date	04/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review