OAT · Class II · 21 CFR 872.3640

FDA Product Code OAT: Implant, Endosseous, Orthodontic

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.

Leading manufacturers include Biomaterials Korea, Inc., Bomei Co, Ltd. and Synthes (Usa).

52
Total
52
Cleared
215d
Avg days
1998
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 189d avg (recent)

FDA 510(k) Cleared Implant, Endosseous, Orthodontic Devices (Product Code OAT)

52 devices
1–24 of 52
Cleared May 19, 2026
OrthoEasy Pal
K260268
Bernhard Förster GmbH (Bernhard Foerster Ltd.)
Dental · 111d
Cleared Jun 19, 2025
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944
Leone S.P.A.
Dental · 267d
Cleared Sep 04, 2024
Mini Screws
K231502
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 469d
Cleared Feb 08, 2024
T-FIT
K231913
Techwin Co., Ltd.
Dental · 224d
Cleared Aug 21, 2023
ACR Screw System
K222245
Biomaterials Korea, Inc.
Dental · 391d
Cleared Oct 07, 2022
Mico One Orthodontic Screw
K202163
Ze Fang Technology Co., Ltd.
Dental · 795d
Cleared Apr 28, 2022
Ortholock Anchorage Devices
K202691
Craniofacial Technologies, Inc.
Dental · 590d
Cleared Dec 19, 2021
ATOZ Mini-Screw
K210559
Mk Meditech, Inc.
Dental · 297d
Cleared Oct 15, 2021
Ortho MI System
K211992
Osteonic Co., Ltd.
Dental · 109d
Cleared Sep 17, 2021
Syntec Orthodontic Mini Screw Extended System
K202790
Syntec Scientific Corporation
Dental · 360d
Cleared Jan 08, 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278
Bomei Co, Ltd.
Dental · 150d
Cleared Dec 17, 2020
Blue Sky Bio TAD
K201919
Blue Sky Bio, LLC
Dental · 160d
Cleared Aug 28, 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041
Gni Co., Ltd.
Dental · 497d
Cleared Jan 17, 2020
Bio-TackS Orthodontic Mini Implant
K190871
Biocetec Co., Ltd.
Dental · 289d
Cleared Nov 06, 2019
BIO-RAY A-1 Anchor Screw System
K182929
Microware Precision Co., Ltd.
Dental · 380d
Cleared Feb 05, 2019
Absoanchor Microimplant
K181142
Dentos, Inc.
Dental · 280d
Cleared Aug 30, 2018
Anchor plate
K173623
Biomaterials Korea, Inc.
Dental · 279d
Cleared Feb 23, 2017
Dual Top Screw System
K161335
Jeil Medical Corporation
Dental · 287d
Cleared Dec 21, 2016
Orthodontic Screw
K161197
Osstem Implant Co., Ltd.
Dental · 237d
Cleared Feb 09, 2016
OBS Anchorage Screw
K152297
Bomei Co, Ltd.
Dental · 180d
Cleared Mar 18, 2015
SYNTEC WETALI ORTHODONTIC MINI SCREWS
K142001
Syntec Scientific Corporation - Taipei Office
Dental · 238d
Cleared Jan 08, 2014
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
K130476
Dental Morelli
Dental · 317d
Cleared Apr 11, 2013
STORM MINI SCREW
K122069
Lancer Orthodontics, Inc.
Dental · 269d
Cleared Feb 21, 2013
FIN-S MICROIMPLANT
K120861
Creekside Orthodontics
Dental · 336d

About Product Code OAT - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code OAT since 1998, with 52 receiving FDA clearance (average review time: 215 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - OAT Product Code

FDA review times for OAT submissions have been consistent, averaging 189 days recently vs 216 days historically.

OAT devices are reviewed by the Dental panel. Browse all Dental devices →