FDA 510(k) Application Details - K182881

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K182881
Device Name	Screw, Fixation, Intraosseous
Applicant	Osstem Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan 612-070 KR Other 510(k) Applications for this Company
Contact	Jungmin Yoo Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2018
Decision Date	08/09/2019
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