Device Classification Name |
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device |
510(K) Number |
K231557 |
Device Name |
Abutment, Implant, Dental, Endosseous |
Applicant |
Izenimplant Co., Ltd.
1, 2Dong, 26-32, Suworam 4-Gil, Seotan-Myeon
Pyeongtaek-Si 17703 KR
Other 510(k) Applications for this Company
|
Contact |
Ji-Hwan Jeong
Other 510(k) Applications for this Contact |
Regulation Number |
872.3630
More FDA Info for this Regulation Number |
Classification Product Code |
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/30/2023 |
Decision Date |
08/24/2023 |
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 |
|