FDA 510(k) Application Details - K231793

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K231793
Device Name	Mouthguard, Prescription
Applicant	Belport Company, Inc., Gingi-Pak 4825 Calle Alto Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	Jingtian Peng 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	06/20/2023
Decision Date	03/26/2024
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