FDA 510(k) Application Details - K251616

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K251616
Device Name	Aligner, Sequential
Applicant	ODS Co., Ltd. 30 Songdomirae-ro, Yeonsu-gu D-1204 Incheon 21990 KR Other 510(k) Applications for this Company
Contact	Kyung-Ran Back 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	05/27/2025
Decision Date	07/22/2025
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