FDA 510(k) Application Details - K203554

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K203554
Device Name	Implant, Endosseous, Root-Form
Applicant	MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil Daegu 42921 KR Other 510(k) Applications for this Company
Contact	You Jung Kim Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2020
Decision Date	08/28/2021
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