FDA 510(k) Applications for Medical Device Product Code "OAT"
(Implant, Endosseous, Orthodontic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061397 | ACE SURGICAL SUPPLY CO., INC. | 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 | 08/16/2006 |
| K063770 | ALPHA-BIO TEC LTD | ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM | 03/26/2007 |
| K190871 | Bio Cetec Co., Ltd. | Bio-TackS Orthodontic Mini Implant | 01/17/2020 |
| K063495 | BIOMATERIALS KOREA INC. | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | 07/26/2007 |
| K111809 | BIOMATERIALS KOREA INC. | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | 09/26/2011 |
| K222245 | BioMaterials Korea, Inc | ACR Screw System | 08/21/2023 |
| K173623 | BioMaterials Korea, Inc | Anchor plate | 08/30/2018 |
| K201919 | Blue Sky Bio, LLC. | Blue Sky Bio TAD | 12/17/2020 |
| K202278 | Bomei Co, Ltd. | OBS Anchorage Screw, Biokey Anchorage Screw | 01/08/2021 |
| K152297 | BOMEI CO., LTD | OBS Anchorage Screw | 02/09/2016 |
| K113650 | BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC | ORTHOFIX SCREW | 10/03/2012 |
| K202691 | Craniofacial Technologies, Inc. | Ortholock Anchorage Devices | 04/28/2022 |
| K120861 | CREEKSIDE ORTHODONTICS | FIN-S MICROIMPLANT | 02/21/2013 |
| K100633 | D B ORTHODONTICS LTD | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 | 04/01/2010 |
| K072086 | D B ORTHODONTICS LTD | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | 10/26/2007 |
| K130476 | DENTAL MORELLI | ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE | 01/08/2014 |
| K062732 | DENTAURUM | TOMAS PIN 6 MM | 10/25/2006 |
| K062733 | DENTAURUM | TOMAS PIN SD 6, 8, AND 10 MM | 11/09/2006 |
| K042965 | DENTAURUM, INC. | TOMAS PIN | 04/15/2005 |
| K181142 | Dentos Inc | Absoanchor Microimplant | 02/05/2019 |
| K110275 | FORESTADENT BERNHARD FORSTER GMBH | ORTHO EASY PIN | 06/03/2011 |
| K081393 | G & H WIRE CO. | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | 08/21/2008 |
| K191041 | GNI Co., LTD | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | 08/28/2020 |
| K091390 | HDC S.R.L. | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 | 07/30/2009 |
| K060062 | INSTITUT STRAUMANN AG | STRAUMANN ORTHOSYSTEM | 02/03/2006 |
| K161335 | JEIL MEDICAL CORPORATION | Dual Top Screw System | 02/23/2017 |
| K102769 | JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | 02/23/2011 |
| K122069 | LANCER ORTHODONTICS, INC. | STORM MINI SCREW | 04/11/2013 |
| K071490 | LEONE SPA | LEONE ORTHODONTIC MINI IMPLANT | 02/22/2008 |
| K073461 | M.I.S. IMPLANTS TECHNOLOGIES LTD. | ORTHO ANCHOR SCREWS | 01/25/2008 |
| K182929 | Microware Precision Co., Ltd. | BIO-RAY A-1 Anchor Screw System | 11/06/2019 |
| K210559 | MK Meditech Inc. | ATOZ Mini-Screw | 12/19/2021 |
| K061266 | ORTHO ORGANIZERS, INC. | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | 07/31/2006 |
| K161197 | OSSTEM IMPLANT CO., LTD. | Orthodontic Screw | 12/21/2016 |
| K103105 | OSSTEM IMPLANT CO.,LTD | ORTHODONTIC SCREW | 03/25/2011 |
| K211992 | Osteonic Co., Ltd. | Ortho MI System | 10/15/2021 |
| K110392 | PSM MEDICAL SOLUTIONS | PSM LOMAS / BENEFIT SCREWS | 12/14/2011 |
| K982509 | STRAUMANN USA | ORTHO IMPLANT AND ACCESSORIES | 09/30/1998 |
| K061230 | SYBRON DENTAL SPECIALTIES | VECTORS TEMPORARY ANCHORAGE SYSTEM | 08/03/2006 |
| K090476 | SYNTEC SCIENTIFIC CORP. | SYNTEC ORTHODONTIC MINI SCREW | 06/18/2009 |
| K202790 | Syntec Scientific Corporation | Syntec Orthodontic Mini Screw Extended System | 09/17/2021 |
| K142001 | SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE | SYNTEC WETALI ORTHODONTIC MINI SCREWS | 03/18/2015 |
| K063473 | SYNTHES (USA) | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | 03/08/2007 |
| K093299 | SYNTHES (USA) | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | 12/16/2010 |
| K063149 | T.O.A.D.S., LLC. | ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) | 03/08/2007 |
| K040469 | THE STRAUMANN CO. | THE STRAUMANN ORTHO IMPLANT SYSTEM | 04/30/2004 |
| K063386 | WALTER LORENZ SURGICAL, INC. | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | 02/09/2007 |
| K202163 | Ze Fang Technology Co., Ltd. | Mico One Orthodontic Screw | 10/07/2022 |
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