Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K212517 |
Device Name |
Magicore System |
Applicant |
InnoBioSurg Co., Ltd. |
44-19, Techno 10-ro, Yuseong-gu |
Daejeon,
KR
34027
|
|
Applicant Contact |
JongHyuk Seo |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/10/2021 |
Decision Date | 10/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|