OAT — Implant, Endosseous, Orthodontic Class II
FDA product code OAT covers "Implant, Endosseous, Orthodontic", a Class II medical device regulated under 21 CFR 872.3640. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAT
- Device Class
- Class II
- Regulation Number
- 872.3640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260268 | bernhard förster gmbh (bernhard foerster ltd.) | OrthoEasy Pal; OrthoEasy Pal Long Neck | May 19, 2026 |
| K242944 | leone | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | June 19, 2025 |
| K231502 | proimtech saglik urunleri anonim sirketi | Mini Screws | September 4, 2024 |
| K231913 | techwin co | T-FIT | February 8, 2024 |
| K222245 | biomaterials korea | ACR Screw System | August 21, 2023 |
| K202163 | ze fang technology co | Mico One Orthodontic Screw | October 7, 2022 |
| K202691 | craniofacial technologies | Ortholock Anchorage Devices | April 28, 2022 |
| K210559 | mk meditech | ATOZ Mini-Screw | December 19, 2021 |
| K211992 | osteonic co | Ortho MI System | October 15, 2021 |
| K202790 | syntec scientific corporation | Syntec Orthodontic Mini Screw Extended System | September 17, 2021 |
| K202278 | bomei co | OBS Anchorage Screw, Biokey Anchorage Screw | January 8, 2021 |
| K201919 | blue sky bio | Blue Sky Bio TAD | December 17, 2020 |
| K191041 | gni co | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | August 28, 2020 |
| K190871 | biocetec co | Bio-TackS Orthodontic Mini Implant | January 17, 2020 |
| K182929 | microware precision co | BIO-RAY A-1 Anchor Screw System | November 6, 2019 |
| K181142 | dentos | Absoanchor Microimplant | February 5, 2019 |
| K173623 | biomaterials korea | Anchor plate | August 30, 2018 |
| K161335 | jeil medical corporation | Dual Top Screw System | February 23, 2017 |
| K161197 | osstem implant co | Orthodontic Screw | December 21, 2016 |
| K152297 | bomei co | OBS Anchorage Screw | February 9, 2016 |