ClearanceBrief
Panels › Dental › Product code OAT · Class 2

Implant, Endosseous, Orthodontic

Regulation 872.3640

1510(k)s in 12 months (52 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in OAT

Company510(k)sRecalls
Biomaterials Korea, Inc.40
Straumann USA22
Dentaurum30
Bomei Co, Ltd.20
D B Orthodontics, Ltd.20
Leone S.P.A.20
Osstem Implant Co., Ltd.20
Syntec Scientific Corp.20
Synthes (Usa)20
Ace Surgical Supply Co., Inc.10
Decided510(k)Device and applicantCode
May 19, 2026K260268OrthoEasy Pal; OrthoEasy Pal Long Neck
Bernhard Förster GmbH (Bernhard Foerster Ltd.), DE
OAT
Jun 19, 2025K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)
Leone S.P.A., IT
OAT
Sep 4, 2024K231502Mini Screws
Proimtech Saglik Urunleri Anonim Sirketi, TR
OAT
Feb 8, 2024K231913T-FIT
Techwin Co., Ltd., KR
OAT
Aug 21, 2023K222245ACR Screw System
Biomaterials Korea, Inc., KR
OAT
Oct 7, 2022K202163Mico One Orthodontic Screw
Ze Fang Technology Co., Ltd., TW
OAT
Apr 28, 2022K202691Ortholock Anchorage Devices
Craniofacial Technologies, Inc.
OAT
Dec 19, 2021K210559ATOZ Mini-Screw
Mk Meditech, Inc., KR
OAT
Oct 15, 2021K211992Ortho MI System
Osteonic Co., Ltd., KR
OAT
Sep 17, 2021K202790Syntec Orthodontic Mini Screw Extended System
Syntec Scientific Corporation, TW
OAT
Jan 8, 2021K202278OBS Anchorage Screw, Biokey Anchorage Screw
Bomei Co, Ltd., TW
OAT
Dec 17, 2020K201919Blue Sky Bio TAD
Blue Sky Bio, LLC
OAT
Aug 28, 2020K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]
Gni Co., Ltd., KR
OAT
Jan 17, 2020K190871Bio-TackS Orthodontic Mini Implant
Biocetec Co., Ltd., KR
OAT
Nov 6, 2019K182929BIO-RAY A-1 Anchor Screw System
Microware Precision Co., Ltd., TW
OAT
Feb 5, 2019K181142Absoanchor Microimplant
Dentos, Inc., KR
OAT
Aug 30, 2018K173623Anchor plate
Biomaterials Korea, Inc., KR
OAT
Feb 23, 2017K161335Dual Top Screw System
Jeil Medical Corporation, KR
OAT
Dec 21, 2016K161197Orthodontic Screw
Osstem Implant Co., Ltd., KR
OAT
Feb 9, 2016K152297OBS Anchorage Screw
Bomei Co, Ltd., TW
OAT
Mar 18, 2015K142001SYNTEC WETALI ORTHODONTIC MINI SCREWS
Syntec Scientific Corporation - Taipei Office, TW
OAT
Jan 8, 2014K130476ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
Dental Morelli
OAT
Apr 11, 2013K122069STORM MINI SCREW
Lancer Orthodontics, Inc.
OAT
Feb 21, 2013K120861FIN-S MICROIMPLANT
Creekside Orthodontics
OAT
Oct 3, 2012K113650ORTHOFIX SCREW
Bonafix Surgical and Dental Implants, LLC
OAT
Dec 14, 2011K110392PSM LOMAS / BENEFIT SCREWS
Psm Medical Solutions, DE
OAT
Sep 26, 2011K111809SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
Biomaterials Korea, Inc.
OAT
Jun 3, 2011K110275ORTHO EASY PIN
Forestadent Bernhard Forster GmbH
OAT
Mar 25, 2011K103105ORTHODONTIC SCREW
Osstem Implant Co., Ltd.
OAT
Feb 23, 2011K102769NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
Jjgc Industria E Comercio DE Materiais Dentarios S
OAT
Dec 16, 2010K093299SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
Synthes (Usa)
OAT
Apr 1, 2010K100633INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
D B Orthodontics, Ltd., GB
OAT
Jul 30, 2009K091390HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
Hdc S.R.L., IT
OAT
Jun 18, 2009K090476SYNTEC ORTHODONTIC MINI SCREW
Syntec Scientific Corp., TW
OAT
Aug 21, 2008K081393ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
G & H Wire Co.
OAT
Feb 22, 2008K071490LEONE ORTHODONTIC MINI IMPLANT
Leone S.P.A., IT
OAT
Jan 25, 2008K073461ORTHO ANCHOR SCREWS
Mis Implants Technologies , Ltd., IL
OAT
Oct 26, 2007K072086INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
D B Orthodontics, Ltd., GB
OAT
Jul 26, 2007K063495C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
Biomaterials Korea, Inc.
OAT
Mar 26, 2007K063770ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
Alpha-Bio Tec , Ltd.
OAT
Mar 8, 2007K063473SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
Synthes (Usa)
OAT
Mar 8, 2007K063149ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
T.O.A.D.S., LLC
OAT
Feb 9, 2007K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEM
Walter Lorenz Surgical, Inc.
OAT
Nov 9, 2006K062733TOMAS PIN SD 6, 8, AND 10 MM
Dentaurum
OAT
Oct 25, 2006K062732TOMAS PIN 6 MM
Dentaurum
OAT
Aug 16, 2006K061397ACE 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.
OAT
Aug 3, 2006K061230VECTORS TEMPORARY ANCHORAGE SYSTEM
Sybron Dental Specialties
OAT
Jul 31, 2006K061266ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
Ortho Organizers, Inc.
OAT
Feb 3, 2006K060062STRAUMANN ORTHOSYSTEM
Institut Straumann AG
OAT
Apr 15, 2005K042965TOMAS PIN
Dentaurum, Inc.
OAT

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