FDA 510(k) Application Details - K232564

Device Classification Name	More FDA Info for this Device
510(K) Number	K232564
Device Name	Align Studio
Applicant	Laon Medi Inc. 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu Seongnam-si 13511 KR Other 510(k) Applications for this Company
Contact	Mina Yun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2023
Decision Date	03/12/2024
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