FDA 510(k) Application Details - K183347

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K183347
Device Name	Unit, Operative Dental
Applicant	Osstem Implant Co., Ltd. 1st Floor, B-dong, 135 Gasan Digital 2-ro, Geumcheon-gu Seoul 08504 KR Other 510(k) Applications for this Company
Contact	Hyeri Han 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	12/03/2018
Decision Date	09/04/2019
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