Mico One Orthodontic Screw
FDA 510(k) K202163 · Ze Fang Technology Co., Ltd.
510(k) numberK202163
Submission
- Device name
- Mico One Orthodontic Screw
- Applicant
- Ze Fang Technology Co., Ltd.
Taichung, TW - Received
- August 3, 2020
- Decision date
- October 7, 2022
- 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.
Other 510(k)s with product code OAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long NeckOAT · Traditional | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 05/19/2026SE |
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device)OAT · Traditional | Leone S.P.A. | 06/19/2025SE |
| K231502 | Mini ScrewsOAT · Traditional | Proimtech Saglik Urunleri Anonim Sirketi | 09/04/2024SE |
| K231913 | T-FitOAT · Traditional | Techwin Co., Ltd. | 02/08/2024SE |
| K222245 | ACR Screw SystemOAT · Traditional | Biomaterials Korea, Inc. | 08/21/2023SE |
| K202691 | Ortholock Anchorage DevicesOAT · Traditional | Craniofacial Technologies, Inc. | 04/28/2022SE |
| K210559 | ATOZ Mini-ScrewOAT · Traditional | Mk Meditech, Inc. | 12/19/2021SE |
| K211992 | Ortho MI SystemOAT · Traditional | Osteonic Co., Ltd. | 10/15/2021SE |
| 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 |
Questions and answers
When was Mico One Orthodontic Screw cleared by the FDA?
Mico One Orthodontic Screw (K202163) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 795 days after the submission was received.
What is the product code of K202163?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.