FDA Product Code
FDA Product Code OAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3640
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | 2026-05-19 | Traditional | PDF ↗ |
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025-06-19 | Traditional | PDF ↗ |
| K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | 2024-09-04 | Traditional | PDF ↗ |
| K231913 | T-FIT | Techwin Co., Ltd. | 2024-02-08 | Traditional | PDF ↗ |
| K222245 | ACR Screw System | Biomaterials Korea, Inc. | 2023-08-21 | Traditional | PDF ↗ |
| K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | 2022-10-07 | Traditional | PDF ↗ |
| K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | 2022-04-28 | Traditional | PDF ↗ |
| K210559 | ATOZ Mini-Screw | Mk Meditech, Inc. | 2021-12-19 | Traditional | PDF ↗ |
| K211992 | Ortho MI System | Osteonic Co., Ltd. | 2021-10-15 | Traditional | PDF ↗ |
| K202790 | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation | 2021-09-17 | Special | PDF ↗ |
| K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. | 2021-01-08 | Special | PDF ↗ |
| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | 2020-12-17 | Traditional | PDF ↗ |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | 2020-08-28 | Traditional | PDF ↗ |
| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | 2020-01-17 | Traditional | PDF ↗ |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | 2019-11-06 | Traditional | PDF ↗ |
| K181142 | Absoanchor Microimplant | Dentos, Inc. | 2019-02-05 | Traditional | PDF ↗ |
| K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018-08-30 | Traditional | PDF ↗ |
| K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017-02-23 | Traditional | PDF ↗ |
| K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | 2016-12-21 | Traditional | PDF ↗ |
| K152297 | OBS Anchorage Screw | Bomei Co, Ltd. | 2016-02-09 | Traditional | PDF ↗ |
| K142001 | SYNTEC WETALI ORTHODONTIC MINI SCREWS | Syntec Scientific Corporation - Taipei Office | 2015-03-18 | Traditional | PDF ↗ |
| K130476 | ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE | Dental Morelli | 2014-01-08 | Traditional | PDF ↗ |
| K122069 | STORM MINI SCREW | Lancer Orthodontics, Inc. | 2013-04-11 | Traditional | PDF ↗ |
| K120861 | FIN-S MICROIMPLANT | Creekside Orthodontics | 2013-02-21 | Traditional | PDF ↗ |
| K113650 | ORTHOFIX SCREW | Bonafix Surgical and Dental Implants, LLC | 2012-10-03 | Traditional | PDF ↗ |
| K110392 | PSM LOMAS / BENEFIT SCREWS | Psm Medical Solutions | 2011-12-14 | Traditional | PDF ↗ |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. | 2011-09-26 | Special | PDF ↗ |
| K110275 | ORTHO EASY PIN | Forestadent Bernhard Forster GmbH | 2011-06-03 | Traditional | PDF ↗ |
| K103105 | ORTHODONTIC SCREW | Osstem Implant Co., Ltd. | 2011-03-25 | Special | PDF ↗ |
| K102769 | NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011-02-23 | Traditional | PDF ↗ |
| K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) | 2010-12-16 | Traditional | PDF ↗ |
| K100633 | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 | D B Orthodontics, Ltd. | 2010-04-01 | Special | PDF ↗ |
| K091390 | HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 | Hdc S.R.L. | 2009-07-30 | Special | PDF ↗ |
| K090476 | SYNTEC ORTHODONTIC MINI SCREW | Syntec Scientific Corp. | 2009-06-18 | Traditional | PDF ↗ |
| K081393 | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW | G & H Wire Co. | 2008-08-21 | Traditional | PDF ↗ |
| K071490 | LEONE ORTHODONTIC MINI IMPLANT | Leone S.P.A. | 2008-02-22 | Traditional | PDF ↗ |
| K073461 | ORTHO ANCHOR SCREWS | Mis Implants Technologies , Ltd. | 2008-01-25 | Traditional | PDF ↗ |
| K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | D B Orthodontics, Ltd. | 2007-10-26 | Traditional | PDF ↗ |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. | 2007-07-26 | Traditional | PDF ↗ |
| K063770 | ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-26 | Traditional | PDF ↗ |
| K063473 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Synthes (Usa) | 2007-03-08 | Traditional | PDF ↗ |
| K063149 | ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) | T.O.A.D.S., LLC | 2007-03-08 | Traditional | PDF ↗ |
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Walter Lorenz Surgical, Inc. | 2007-02-09 | Traditional | PDF ↗ |
| K062733 | TOMAS PIN SD 6, 8, AND 10 MM | Dentaurum | 2006-11-09 | Traditional | PDF ↗ |
| K062732 | TOMAS PIN 6 MM | Dentaurum | 2006-10-25 | Traditional | PDF ↗ |
| 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 Co., Inc. | 2006-08-16 | Traditional | PDF ↗ |
| K061230 | VECTORS TEMPORARY ANCHORAGE SYSTEM | Sybron Dental Specialties | 2006-08-03 | Traditional | PDF ↗ |
| K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | Ortho Organizers, Inc. | 2006-07-31 | Traditional | PDF ↗ |
| K060062 | STRAUMANN ORTHOSYSTEM | Institut Straumann AG | 2006-02-03 | Special | PDF ↗ |
| K042965 | TOMAS PIN | Dentaurum, Inc. | 2005-04-15 | Traditional | PDF ↗ |
| K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM | The Straumann Co. | 2004-04-30 | Traditional | PDF ↗ |
| K982509 | ORTHO IMPLANT AND ACCESSORIES | Straumann USA | 1998-09-30 | Traditional | PDF ↗ |
Product code OAT · Class II · Dental. Data: openFDA.