FDA 510(k) Application Details - K243103

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K243103
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Riton 3D Technology Co., Ltd Room C101, Building 2, No. 21, Hejing South Road Liwan District Guangzhou 51038 CN Other 510(k) Applications for this Company
Contact	Zhou BinBin Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	12/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review