Ortho MI System — Osteonic Co., Ltd. (510(k) K211992)
Ortho MI System — Osteonic Co., Ltd. (510(k) K211992) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Ortho MI System; Applicant: Osteonic Co., Ltd.; Clearance track: 510(k).
| Device name | Ortho MI System |
|---|---|
| Applicant | Osteonic Co., Ltd. |
| Clearance track | 510(k) |
| Submission number | K211992 |
| Decision | Substantially Equivalent |
| Decision date | 2021-10-15 |
| Date received | 2021-06-28 |
| Product code | OAT |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | KR |
| Source | openFDA device |
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