Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K210161 |
Device Name |
AnyOne Onestage Implant System |
Applicant |
MegaGen Implant Co., Ltd. |
45, Secheon-ro, 7-gil |
Daegu,
KR
42921
|
|
Applicant Contact |
You Jung Kim |
Correspondent |
DaeGyeong Regulatory Affairs Institute |
32, Innovalley-ro |
Daegu,
KR
41065
|
|
Correspondent Contact |
You Jung Kim |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/21/2021 |
Decision Date | 06/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|