Implant, Endosseous, Orthodontic
FDA product code OAT · Class II (moderate risk) · 21 CFR 872.3640 · Dental
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.
52510(k) clearances
0PMA approvals
3recalls
Implantimplanted device
Manufacturers
- Biomaterials Korea, Inc. 4
- Dentaurum 3
- Bomei Co, Ltd. 2
- Osstem Implant Co., Ltd. 2
- Syntec Scientific Corp. 2
- Leone S.P.A. 2
- Synthes (Usa) 2
- D B Orthodontics, Ltd. 2
- Alpha-Bio Tec , Ltd. 1
- Bernhard Förster GmbH (Bernhard Foerster Ltd.) 1
- Hdc S.R.L. 1
- G & H Wire Co. 1
- Mis Implants Technologies , Ltd. 1
- Straumann USA 1
- T.O.A.D.S., LLC 1
- Walter Lorenz Surgical, Inc. 1
- Ace Surgical Supply Co., Inc. 1
- Sybron Dental Specialties, Inc. 1
- Ortho Organizers, Inc. 1
- Institut Straumann AG 1
510(k) clearances
| 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 |
| K202278 | OBS Anchorage Screw, Biokey Anchorage ScrewOAT · Special | Bomei Co, Ltd. | 01/08/2021SE |
| K201919 | Blue Sky Bio TADOAT · Traditional | Blue Sky Bio, LLC | 12/17/2020SE |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew]OAT · Traditional | Gni Co., Ltd. | 08/28/2020SE |
| K190871 | Bio-TackS Orthodontic Mini ImplantOAT · Traditional | Biocetec Co., Ltd. | 01/17/2020SE |
| K182929 | BIO-RAY A-1 Anchor Screw SystemOAT · Traditional | Microware Precision Co., Ltd. | 11/06/2019SE |
| K181142 | Absoanchor MicroimplantOAT · Traditional | Dentos, Inc. | 02/05/2019SE |
| K173623 | Anchor plateOAT · Traditional | Biomaterials Korea, Inc. | 08/30/2018SE |
| K161335 | Dual Top Screw SystemOAT · Traditional | Jeil Medical Corporation | 02/23/2017SE |
| K161197 | Orthodontic ScrewOAT · Traditional | Osstem Implant Co., Ltd. | 12/21/2016SE |
| K152297 | OBS Anchorage ScrewOAT · Traditional | Bomei Co, Ltd. | 02/09/2016SE |
| K142001 | Syntec Wetali Orthodontic Mini ScrewsOAT · Traditional | Syntec Scientific Corporation - Taipei Office | 03/18/2015SE |
| K130476 | Orthodontic Miniscrew for Absolute AnchorageOAT · Traditional | Dental Morelli | 01/08/2014SE |
| K122069 | Storm Mini ScrewOAT · Traditional | Lancer Orthodontics, Inc. | 04/11/2013SE |
| K120861 | Fin-S MicroimplantOAT · Traditional | Creekside Orthodontics | 02/21/2013SE |
| K113650 | Orthofix ScrewOAT · Traditional | Bonafix Surgical and Dental Implants, LLC | 10/03/2012SE |
| K110392 | PSM Lomas / Benefit ScrewsOAT · Traditional | Psm Medical Solutions | 12/14/2011SE |
| K111809 | SL Type Orthodontic Anchor Screws, SPL Type Orthodontic Anchor ScrewsOAT · Special | Biomaterials Korea, Inc. | 09/26/2011SE |
| K110275 | Ortho Easy PinOAT · Traditional | Forestadent Bernhard Forster GmbH | 06/03/2011SE |
| K103105 | Orthodontic ScrewOAT · Special | Osstem Implant Co., Ltd. | 03/25/2011SE |
| K102769 | Neodent Implant for Orthodontic AnchorageOAT · Traditional | Jjgc Industria E Comercio DE Materiais Dentarios S | 02/23/2011SE |
| K093299 | Synthes Orthodontic Bone Anchor SystemOAT · Traditional | Synthes (Usa) | 12/16/2010SE |
| K100633 | Infinitas Mini-Implant Model: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016OAT · Special | D B Orthodontics, Ltd. | 04/01/2010SE |
| K091390 | HDC Sterile Self Ligating Spider Screw, Model SLI,SL2OAT · Special | Hdc S.R.L. | 07/30/2009SE |
| K090476 | Syntec Orthodontic Mini ScrewOAT · Traditional | Syntec Scientific Corp. | 06/18/2009SE |
| K081393 | Orthodontic Temporary Anchorage Implant ScrewOAT · Traditional | G & H Wire Co. | 08/21/2008SE |
| K071490 | Leone Orthodontic Mini ImplantOAT · Traditional | Leone S.P.A. | 02/22/2008SE |
| K073461 | Ortho Anchor ScrewsOAT · Traditional | Mis Implants Technologies , Ltd. | 01/25/2008SE |
| K072086 | Infinitas Mini-Implant System/Guidance SystemOAT · Traditional | D B Orthodontics, Ltd. | 10/26/2007SE |
| K063495 | C Type, CT Type, and Special Type Orthodontic Anchor ScrewsOAT · Traditional | Biomaterials Korea, Inc. | 07/26/2007SE |
| K063770 | Alpha-Bio Orthodontic Fixation Screw SystemOAT · Traditional | Alpha-Bio Tec , Ltd. | 03/26/2007SE |
| K063473 | Synthes Orthodontic Bone Anchor SystemOAT · Traditional | Synthes (Usa) | 03/08/2007SE |
| K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System)OAT · Traditional | T.O.A.D.S., LLC | 03/08/2007SE |
| K063386 | Lorenz Orthodontic Anchorage SystemOAT · Traditional | Walter Lorenz Surgical, Inc. | 02/09/2007SE |
| K062733 | Tomas Pin SD 6, 8, and 10 MMOAT · Traditional | Dentaurum | 11/09/2006SE |
| K062732 | Tomas Pin 6 MMOAT · Traditional | Dentaurum | 10/25/2006SE |
| K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…OAT · Traditional | Ace Surgical Supply Co., Inc. | 08/16/2006SE |
| K061230 | Vectors Temporary Anchorage SystemOAT · Traditional | Sybron Dental Specialties | 08/03/2006SE |
| K061266 | Ortho Organizers Temporary Orthodontic AnchorOAT · Traditional | Ortho Organizers, Inc. | 07/31/2006SE |
| K060062 | Straumann OrthosystemOAT · Special | Institut Straumann AG | 02/03/2006SE |
| K042965 | Tomas PinOAT · Traditional | Dentaurum, Inc. | 04/15/2005SE |
| K040469 | The Straumann Ortho Implant SystemOAT · Traditional | The Straumann Co. | 04/30/2004SE |
| K982509 | Ortho Implant and AccessoriesOAT · Traditional | Straumann USA | 09/30/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2194-2013 Class II | Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm…Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot… | Ormco/Sybronendo | 07/12/2013Terminated |
| Z-0278-2008 | Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC…Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during… | Straumann USA LLC | 09/28/2007Terminated |
| Z-0277-2008 | Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA.…Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during… | Straumann USA LLC | 09/28/2007Terminated |