FDA 510(k) Application Details - K181361

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K181361
Device Name	Mouthguard, Prescription
Applicant	Brux Night Guard 8201 Canoga Ave. #9066 Canoga Park, CA 91309 US Other 510(k) Applications for this Company
Contact	John Scalco 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	05/23/2018
Decision Date	04/11/2019
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