Prosthetic devices · 21 CFR 872 Subpart D
Orthodontic Endosseous Implant
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.
- Companies listing it
- 4532 makers
- Brands and models
- 112
- 510(k) clearances
- 528 in five years
- FDA name
- Implant, Endosseous, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list OAT
45 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Neodent Implant for Orthodontic Anchorage · Straumann Dental Implant System | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Orthodontic Anchor Screw | 148 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | OrthAnchor · Orthodontic Screw | 68 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Bio TAD | 20 | 2024 |
| Zentek Medical LLC | United States | Maker | Orthodontic screw | 3 | 2025 |
| Jeil Medical Corporation | South Korea | Maker | Dual Top Anchor System · 112-070 kit | 9 | 2026 |
| Biomaterials Korea, Inc. | South Korea | Maker | ACR · Anchor Plate · OAS-T1809-SP · OAS-T1811-SP · +1 | 5 | 2023 |
| Leone S.P.A. | Italy | Maker | Leone Orthodontic Mini Implant | 4 | 2025 |
| Microware Precision Co., Ltd. | Taiwan | Maker | BIO-RAY A-1 Anchor Screw System · Orthodontic Ortholock Screw | 2 | 2022 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | AS Orthodontic Screw 1.5mm L07mm round hole SS · AS Orthodontic Screw 1.5mm L07mm round hole Ti · AS Orthodontic Screw 1.5mm L07mm square hole SS · AS Orthodontic Screw 1.5mm L07mm square hole Ti · +50 | 1 | 2022 |
| MK Meditech | South Korea | Maker | ATOZ Mini-Screw | 1 | 2021 |
| Biomet Microfixation | United States | Maker | ORTHODONTIC ANCHORAGE SYSTEM | 8 | 2021 |
| SYNTHES (USA) Products LLC | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional · ORTHODONTIC BONE ANCHOR SYSTEM · SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | 7 | 2020 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Ortho Easy Pin · OrthoEasy Pal · OrthoEasy Pal Long Neck | 4 | 2011 |
| OSTEONIC Co., Ltd. | South Korea | Maker | ORTHO MI SYSTEM | 3 | 2021 |
| GNI Co., LTD | South Korea | Maker | — | 3 | 2021 |
| Odontit S.A. | Argentina | Maker | Kalos Biomedical · ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE | 3 | 2014 |
| Hdc S.R.L. | Italy | Maker | Sterile Self Ligating Spider Screw | 3 | 2009 |
| Dentos, Inc. | South Korea | Maker | — | 2 | 2019 |
| DB Orthodontics Limited | United Kingdom | Maker | Infinitas Orthodontic Mini Implant Non-Sterile · Infinitas Orthodontic Mini Implant Sterile | 2 | 2010 |
| Bomei Co, Ltd. | Taiwan | Maker | — | 2 | 2021 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Dentaurum GmbH & Co. KG | Germany | Maker | tomas · tomas pin | — | — |
| Jabil Inc. | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional | — | — |
| Accumedix, Inc. | United States | Maker | Blue Sky Bio TAD | — | — |
| Superior Machined Products, Inc. | United States | Maker | Odontit | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Eptam West LLC | United States | Maker | OAT - Implant, endosseous, orthodontic | — | — |
| Eminent Spine, LLC | United States | Maker | Cervical Plate System | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Palaxa Precision LLC | United States | Maker | — | — | — |
| alfa gate - mazen ltd. | Israel | Foreign exporter | — | 1 | 2019 |
| Utah Medical Products and Services | United States | Contract manufacturer | BIO-RAY A-1 Anchor Screw System | 1 | 2021 |
| Sotera Health LLC | United States | Contract manufacturer | SELF LIGATING SPIDER SCREW - STERILE | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | DB10-0001 Infinitas Mini Implant - 1.5mmD, 6mmL, Short Neck, Standard Head · DB10-0002 Infinitas Mini Implant - 1.5mmD, 9mmL, Short Neck, Standard Head · DB10-0004 Infinitas Mini Implant - 1.5mmD, 9mmL, Long Neck, Standard Head · DB10-0007 Infinitas Mini Implant - 2mmD, 6mmL, Long Neck, Standard Head · +6 | — | — |
| STERIS Corporation | United States | Contract sterilizer | Accumedix3772 (LS) - Blue Sky Bio TAD · LSO2556 (NT) - Ormco VectorTAS Mini Screw | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Infinity Implant System | — | — |
| Csy International LLC | United States | Repacker / relabeler | GNI · J&J Orthodontics | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | Neodent Implant for Orthodontic Anchorage | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | IMPLANT, ENDOSSEOUS, ORTHODONTIC | — | — |
| Life Science Outsourcing, Inc. | United States | Contract manufacturer | VectorTAS Mini Screw | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| BGS Beta-Gamma-Service GmbH & Co KG | Germany | Contract sterilizer | — | — | — |
| Riverside Medical Packaging Company Ltd | United Kingdom | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 May 2026 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) |
| 19 Jun 2025 | K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. |
| 4 Sep 2024 | K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi |
| 8 Feb 2024 | K231913 | T-FIT | Techwin Co., Ltd. |
| 21 Aug 2023 | K222245 | ACR Screw System | Biomaterials Korea, Inc. |
| 7 Oct 2022 | K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. |
| 28 Apr 2022 | K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. |
| 19 Dec 2021 | K210559 | ATOZ Mini-Screw | MK Meditech |
| 15 Oct 2021 | K211992 | Ortho MI System | OSTEONIC Co., Ltd. |
| 17 Sep 2021 | K202790 | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation |
| 8 Jan 2021 | K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. |
| 17 Dec 2020 | K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC |
| 28 Aug 2020 | K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | GNI Co., LTD |
| 17 Jan 2020 | K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. |
| 6 Nov 2019 | K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. |
| 5 Feb 2019 | K181142 | Absoanchor Microimplant | Dentos, Inc. |
| 30 Aug 2018 | K173623 | Anchor plate | Biomaterials Korea, Inc. |
| 23 Feb 2017 | K161335 | Dual Top Screw System | Jeil Medical Corporation |
| 21 Dec 2016 | K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. |
| 9 Feb 2016 | K152297 | OBS Anchorage Screw | Bomei Co, Ltd. |
| 18 Mar 2015 | K142001 | SYNTEC WETALI ORTHODONTIC MINI SCREWS | Syntec Scientific Corporation - Taipei Office |
| 8 Jan 2014 | K130476 | ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE | Dental Morelli |
| 11 Apr 2013 | K122069 | STORM MINI SCREW | Lancer Orthodontics, Inc. |
| 21 Feb 2013 | K120861 | FIN-S MICROIMPLANT | Creekside Orthodontics |
| 3 Oct 2012 | K113650 | ORTHOFIX SCREW | Bonafix Surgical and Dental Implants |
| 14 Dec 2011 | K110392 | PSM LOMAS / BENEFIT SCREWS | Psm Medical Solutions |
| 26 Sep 2011 | K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. |
| 3 Jun 2011 | K110275 | ORTHO EASY PIN | Forestadent Bernhard Forster GmbH |
| 25 Mar 2011 | K103105 | ORTHODONTIC SCREW | Osstem Implant Co., Ltd. |
| 23 Feb 2011 | K102769 | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | Jjgc Industria E Comercio DE Materiais Dentarios S |
| 16 Dec 2010 | K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) |
| 1 Apr 2010 | K100633 | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 | DB Orthodontics Limited |
| 30 Jul 2009 | K091390 | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 | Hdc S.R.L. |
| 18 Jun 2009 | K090476 | SYNTEC ORTHODONTIC MINI SCREW | Syntec Scientific Corporation |
| 21 Aug 2008 | K081393 | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | G&H Wire Company |
| 22 Feb 2008 | K071490 | LEONE ORTHODONTIC MINI IMPLANT | Leone S.P.A. |
| 25 Jan 2008 | K073461 | ORTHO ANCHOR SCREWS | Dentsply Sirona, Inc. |
| 26 Oct 2007 | K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | DB Orthodontics Limited |
| 26 Jul 2007 | K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. |
| 26 Mar 2007 | K063770 | ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM | Alpha-Bio Tec |
| 8 Mar 2007 | K063473 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) |
| 8 Mar 2007 | K063149 | ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) | T.o.a.d.s., LLC |
| 9 Feb 2007 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Walter Lorenz Surgical, Inc. |
| 9 Nov 2006 | K062733 | TOMAS PIN SD 6, 8, AND 10 MM | Dentaurum |
| 25 Oct 2006 | K062732 | TOMAS PIN 6 MM | Dentaurum |
| 16 Aug 2006 | K061397 | ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M | Ace Surgical Supply Company, Inc. |
| 3 Aug 2006 | K061230 | VECTORS TEMPORARY ANCHORAGE SYSTEM | Sybron Dental Specialties |
| 31 Jul 2006 | K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | Ortho Organizers, Inc. |
| 3 Feb 2006 | K060062 | STRAUMANN ORTHOSYSTEM | Institut Straumann AG |
| 15 Apr 2005 | K042965 | TOMAS PIN | Dentaurum |
| 30 Apr 2004 | K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | The Straumann Co. |
| 30 Sep 1998 | K982509 | ORTHO IMPLANT AND ACCESSORIES | Institut Straumann AG |
Official records: FDA product classification for OAT · 21 CFR 872.3640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026