Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K192614 |
Device Name |
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment |
Applicant |
MegaGen Implant CO., Ltd. |
45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun |
Daegu,
KR
42921
|
|
Applicant Contact |
You Jung Kim |
Correspondent |
MegaGen Implant CO., Ltd. |
45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun |
Daegu,
KR
42921
|
|
Correspondent Contact |
You Jung Kim |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/23/2019 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|