FDA 510(k) Application Details - K250823

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K250823
Device Name	Material, Tooth Shade, Resin
Applicant	Mediclus Co., Ltd. No. 1210, 134 Gongdan-ro, Heungdeok-gu Cheongju-si 28576 KR Other 510(k) Applications for this Company
Contact	Priscilla Chung Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2025
Decision Date	04/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status
Type	Special
Reviewed By Third Party	N
Expedited Review