FDA 510(k) Application Details - K250804

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K250804
Device Name	Coating, Filling Material, Resin
Applicant	ID KOREA CO., LTD. 405, 150, Donggyecheon-ro Dong-gu 61436 KR Other 510(k) Applications for this Company
Contact	Eunhui Lim Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2025
Decision Date	06/04/2025
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