The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Ortho Mi System.
| Device ID | K211992 |
| 510k Number | K211992 |
| Device Name: | Ortho MI System |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Osteonic Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho 1202Ho, 1206Ho, 38 Digital-ro 29-gil Guro-gu, KR 08381 |
| Contact | Lee Jisun |
| Correspondent | Lee Jisun Osteonic Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho 1202Ho, 1206Ho, 38 Digital-ro 29-gil Guro-gu, KR 08381 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-10-15 |