FDA 510(k) Application Details - K211978

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K211978
Device Name	Implant, Endosseous, Root-Form
Applicant	JJ Medical Co., Ltd. Daeryung Techno Town 3 409 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul 08505 KR Other 510(k) Applications for this Company
Contact	Sun Jae Lee 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	06/25/2021
Decision Date	01/05/2022
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