FDA 510(k) Application Details - K223798

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K223798
Device Name	Mouthguard, Prescription
Applicant	Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Jiahe Li 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	12/19/2022
Decision Date	02/17/2023
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