FDA 510(k) Application Details - K241311

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K241311
Device Name	Mouthguard, Prescription
Applicant	Bernhard F÷rster GmbH Westliche Karl-Friedrich-Strasse 151 Pforzheim 75172 DE Other 510(k) Applications for this Company
Contact	Stefan F÷rster 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	05/09/2024
Decision Date	08/02/2024
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