Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K203344 |
Device Name |
Premilled Titanium Block System |
Applicant |
InnoBioSurg Co., Ltd. |
44-19, Techno 10-ro, Yuseong-gu |
Daejeon,
KR
34027
|
|
Applicant Contact |
Sun-Mi Park |
Correspondent |
Withus Group Inc |
106 Superior |
Irvine,
CA
92620
|
|
Correspondent Contact |
April Lee |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/13/2020 |
Decision Date | 08/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|