FDA 510(k) Application Details - K222845

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K222845
Device Name	Mouthguard, Prescription
Applicant	Frey Oral Technologies LLC 433 North Camden Drive, Suite 1070 Beverly Hills, CA 90210 US Other 510(k) Applications for this Company
Contact	David Frey 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	09/21/2022
Decision Date	11/28/2023
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