FDA 510(k) Application Details - K242637

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K242637
Device Name	Aligner, Sequential
Applicant	MEM Dental Technology Co., Ltd. 2F., No. 22, Lane 31, Sec. 1, Huandong Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan City 74146 TW Other 510(k) Applications for this Company
Contact	Maggie Wei Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2024
Decision Date	05/21/2025
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