FDA 510(k) Application Details - K230237

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K230237
Device Name	Mouthguard, Prescription
Applicant	Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. 3-3, No. 10, Tiangui Road, Mudong Town, Banan District Chongqing 401338 CN Other 510(k) Applications for this Company
Contact	Chen Yang 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	01/30/2023
Decision Date	09/14/2023
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