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 Synthes (Usa), Biomaterials Korea, Inc. and Biocetec Co., Ltd..

52
Total
52
Cleared
215d
Avg days
1998
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 282d recently vs 211d historically

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 Dec 16, 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299
Synthes (Usa)
Dental · 421d
Cleared Mar 08, 2007
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473
Synthes (Usa)
Dental · 112d

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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - OAT Product Code

Recent submissions under OAT have taken an average of 282 days to reach a decision - up from 211 days historically. Manufacturers should account for longer review timelines in current project planning.

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