Orthodontic Screw
FDA 510(k) K161197 · Osstem Implant Co., Ltd.
510(k) numberK161197
Submission
- Device name
- Orthodontic Screw
- Applicant
- Osstem Implant Co., Ltd.
Busan, KR - Received
- April 28, 2016
- Decision date
- December 21, 2016
- 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 |
| 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 |
| 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 |
More from Syntec Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K251434 | Healing Abutment SystemNHA · Traditional | 03/04/2026SE |
| K251569 | Bone ScrewDZL · Traditional | 08/13/2025SE |
| K242521 | Estar-ZEEIH · Traditional | 11/20/2024SE |
| K233806 | T2 PlusOAS · Traditional | 09/06/2024SE |
| K233194 | TS Abutment SystemNHA · Traditional | 02/20/2024SE |
| K232220 | SS Abutment SystemNHA · Traditional | 12/05/2023SE |
| K232012 | N1EHD · Traditional | 11/28/2023SE |
| K222778 | Osstem Implant SystemDZE · Traditional | 09/23/2023SE |
| K221684 | Osstem Abutment SystemNHA · Traditional | 09/08/2022SE |
| K212303 | T2OAS · Traditional | 09/21/2021SE |
Questions and answers
When was Orthodontic Screw cleared by the FDA?
Orthodontic Screw (K161197) received a 510(k) decision of Substantially Equivalent on December 21, 2016, 237 days after the submission was received.
What is the product code of K161197?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.