Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K211992 |
Device Name |
Ortho MI System |
Applicant |
Osteonic Co., Ltd. |
303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho |
1202Ho, 1206Ho, 38 Digital-ro 29-gil |
Guro-gu,
KR
08381
|
|
Applicant Contact |
Lee Jisun |
Correspondent |
Osteonic Co., Ltd. |
303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho |
1202Ho, 1206Ho, 38 Digital-ro 29-gil |
Guro-gu,
KR
08381
|
|
Correspondent Contact |
Lee Jisun |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 06/28/2021 |
Decision Date | 10/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|