Atlas FDA

OAT

52 FDA 510(k) clearances · Product code

170 daysmedian time to decision
391 days90th percentile
52clearances measured

FDA profile

Official device name
Implant, Endosseous, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Medical specialty
Dental
Flags
Implant
FDA definition
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.
Adverse events (MAUDE)
2021: 68 · 2022: 84 · 2023: 78 · 2024: 44 · 2025: 39 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OrthoEasy Pal; OrthoEasy Pal Long Neck (K260268)Bernhard Förster GmbH (Bernhard Foerster Ltd.)2026-05-19
Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944)Leone S.P.A.2025-06-19
Mini Screws (K231502)Proimtech Saglik Urunleri Anonim Sirketi2024-09-04
T-FIT (K231913)Techwin Co., Ltd.2024-02-08
ACR Screw System (K222245)Biomaterials Korea, Inc.2023-08-21
Mico One Orthodontic Screw (K202163)Ze Fang Technology Co., Ltd.2022-10-07
Ortholock Anchorage Devices (K202691)Craniofacial Technologies, Inc.2022-04-28
ATOZ Mini-Screw (K210559)Mk Meditech, Inc.2021-12-19
Ortho MI System (K211992)Osteonic Co., Ltd.2021-10-15
Syntec Orthodontic Mini Screw Extended System (K202790)Syntec Scientific Corporation2021-09-17
OBS Anchorage Screw, Biokey Anchorage Screw (K202278)Bomei Co, Ltd.2021-01-08
Blue Sky Bio TAD (K201919)Blue Sky Bio, LLC2020-12-17
Orthodontic Fixation Screw [Smart Anchor Miniscrew] (K191041)Gni Co., Ltd.2020-08-28
Bio-TackS Orthodontic Mini Implant (K190871)Biocetec Co., Ltd.2020-01-17
BIO-RAY A-1 Anchor Screw System (K182929)Microware Precision Co., Ltd.2019-11-06
Absoanchor Microimplant (K181142)Dentos, Inc.2019-02-05
Anchor plate (K173623)Biomaterials Korea, Inc.2018-08-30
Dual Top Screw System (K161335)Jeil Medical Corporation2017-02-23
Orthodontic Screw (K161197)Osstem Implant Co., Ltd.2016-12-21
OBS Anchorage Screw (K152297)Bomei Co, Ltd.2016-02-09
SYNTEC WETALI ORTHODONTIC MINI SCREWS (K142001)Syntec Scientific Corporation - Taipei Office2015-03-18
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE (K130476)Dental Morelli2014-01-08
STORM MINI SCREW (K122069)Lancer Orthodontics, Inc.2013-04-11
FIN-S MICROIMPLANT (K120861)Creekside Orthodontics2013-02-21
ORTHOFIX SCREW (K113650)Bonafix Surgical and Dental Implants, LLC2012-10-03
PSM LOMAS / BENEFIT SCREWS (K110392)Psm Medical Solutions2011-12-14
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS (K111809)Biomaterials Korea, Inc.2011-09-26
ORTHO EASY PIN (K110275)Forestadent Bernhard Forster GmbH2011-06-03
ORTHODONTIC SCREW (K103105)Osstem Implant Co., Ltd.2011-03-25
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE (K102769)Jjgc Industria E Comercio DE Materiais Dentarios S2011-02-23
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K093299)Synthes (Usa)2010-12-16
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 (K100633)D B Orthodontics, Ltd.2010-04-01
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 (K091390)Hdc S.R.L.2009-07-30
SYNTEC ORTHODONTIC MINI SCREW (K090476)Syntec Scientific Corp.2009-06-18
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW (K081393)G & H Wire Co.2008-08-21
LEONE ORTHODONTIC MINI IMPLANT (K071490)Leone S.P.A.2008-02-22
ORTHO ANCHOR SCREWS (K073461)Mis Implants Technologies , Ltd.2008-01-25
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM (K072086)D B Orthodontics, Ltd.2007-10-26
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS (K063495)Biomaterials Korea, Inc.2007-07-26
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM (K063770)Alpha-Bio Tec , Ltd.2007-03-26
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) (K063149)T.O.A.D.S., LLC2007-03-08
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (K063473)Synthes (Usa)2007-03-08
LORENZ ORTHODONTIC ANCHORAGE SYSTEM (K063386)Walter Lorenz Surgical, Inc.2007-02-09
TOMAS PIN SD 6, 8, AND 10 MM (K062733)Dentaurum2006-11-09
TOMAS PIN 6 MM (K062732)Dentaurum2006-10-25
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 (K061397)Ace Surgical Supply Co., Inc.2006-08-16
VECTORS TEMPORARY ANCHORAGE SYSTEM (K061230)Sybron Dental Specialties2006-08-03
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR (K061266)Ortho Organizers, Inc.2006-07-31
STRAUMANN ORTHOSYSTEM (K060062)Institut Straumann AG2006-02-03
TOMAS PIN (K042965)Dentaurum, Inc.2005-04-15
THE STRAUMANN ORTHO IMPLANT SYSTEM (K040469)The Straumann Co.2004-04-30
ORTHO IMPLANT AND ACCESSORIES (K982509)Straumann USA1998-09-30

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Every clearance here is in the API, with alerts when new ones post.