FDA 510(k) Application Details - K232559

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K232559
Device Name	Material, Tooth Shade, Resin
Applicant	Arum Dentistry Co., Ltd. 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon 34002 KR Other 510(k) Applications for this Company
Contact	Boyeon Lim 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	08/23/2023
Decision Date	09/11/2024
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