FDA 510(k) Application Details - K210940

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K210940
Device Name	Mouthguard, Prescription
Applicant	DMG Digital Enterprises SE Elbgaustrasse 248 Hamburg 22547 DE Other 510(k) Applications for this Company
Contact	Stephan Schafer 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	03/29/2021
Decision Date	09/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review