BIO-RAY A-1 Anchor Screw System
FDA 510(k) K182929 · Microware Precision Co., Ltd.
510(k) numberK182929
Submission
- Device name
- BIO-RAY A-1 Anchor Screw System
- Applicant
- Microware Precision Co., Ltd.
Taichung City, TW - Received
- October 22, 2018
- Decision date
- November 6, 2019
- 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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| 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 |
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| K242814 | Tandry Q-Locking Plate SystemHRS · Traditional | 11/14/2024SE |
| K230690 | Tandry Locking Plate SystemHRS · Traditional | 08/17/2023SE |
| K220360 | Tandry CMF Plate SystemJEY · Traditional | 11/10/2022SE |
| K220359 | Tandry Compression Screw SystemHWC · Traditional | 09/20/2022SE |
| K171904 | Tandry Locking Plate SystemHRS · Traditional | 09/18/2018SE |
| K111008 | Microware Bone Plates and Bone ScrewHRS · Special | 05/02/2012SE |
| K072562 | Microware Bone Plates and Bone ScrewsHRS · Traditional | 12/04/2008SE |
Questions and answers
When was BIO-RAY A-1 Anchor Screw System cleared by the FDA?
BIO-RAY A-1 Anchor Screw System (K182929) received a 510(k) decision of Substantially Equivalent on November 6, 2019, 380 days after the submission was received.
What is the product code of K182929?
The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.