Ortho MI System
FDA 510(k) K211992 · Osteonic Co., Ltd.
510(k) numberK211992
Submission
- Device name
- Ortho MI System
- Applicant
- Osteonic Co., Ltd.
Guro-Gu, KR - Received
- June 28, 2021
- Decision date
- October 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAT – Implant, Endosseous, Orthodontic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3640
- Specialty
- Dental
- Implant
- Yes
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
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| K222245 | ACR Screw SystemOAT · Traditional | Biomaterials Korea, Inc. | 08/21/2023SE |
| K202163 | Mico One Orthodontic ScrewOAT · Traditional | Ze Fang Technology Co., Ltd. | 10/07/2022SE |
| K202691 | Ortholock Anchorage DevicesOAT · Traditional | Craniofacial Technologies, Inc. | 04/28/2022SE |
| K210559 | ATOZ Mini-ScrewOAT · Traditional | Mk Meditech, Inc. | 12/19/2021SE |
| K202790 | Syntec Orthodontic Mini Screw Extended SystemOAT · Special | Syntec Scientific Corporation | 09/17/2021SE |
| K202278 | OBS Anchorage Screw, Biokey Anchorage ScrewOAT · Special | Bomei Co, Ltd. | 01/08/2021SE |
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| K231322 | Fix2Lock(PEEK Self Punching)MBI · Special | 06/07/2023SE |
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Questions and answers
When was Ortho MI System cleared by the FDA?
Ortho MI System (K211992) received a 510(k) decision of Substantially Equivalent on October 15, 2021, 109 days after the submission was received.
What is the product code of K211992?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.