FDA 510(k) Application Details - K251491

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K251491
Device Name	Unit, Operative Dental
Applicant	Osstem Implant Company., Ltd. Chair Business 192, Haebong-ro, Danwon-gu Ansan-si 15428 KR Other 510(k) Applications for this Company
Contact	Jimin Hyun Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2025
Decision Date	07/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review