FDA 510(k) Application Details - K250063

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K250063
Device Name	Powder, Porcelain
Applicant	ARUM Dentistry Co., Ltd. 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon 34002 KR Other 510(k) Applications for this Company
Contact	Choi Won-Yi Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	07/10/2025
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