FDA 510(k) Application Details - K240586

Device Classification Name	Teeth, Porcelain   More FDA Info for this Device
510(K) Number	K240586
Device Name	Teeth, Porcelain
Applicant	Hangzhou Thales Medtech Co., Ltd. 1001 Room 3# First Floor, 1Building, 8 Block Zhuantang Technological and Economic Zone, Xihu District Hangzhou 310000 CN Other 510(k) Applications for this Company
Contact	Wang Shuo Other 510(k) Applications for this Contact
Regulation Number	872.3920   More FDA Info for this Regulation Number
Classification Product Code	ELL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2024
Decision Date	10/03/2024
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