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OAT — Implant, Endosseous, Orthodontic Class II

FDA Device Classification

Classification Details

Product Code
OAT
Device Class
Class II
Regulation Number
872.3640
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242944leoneLeone Orthodontic Implant TAD (Temporary Anchorage Device)June 19, 2025
K231502proimtech saglik urunleri anonim sirketiMini ScrewsSeptember 4, 2024
K231913techwin coT-FITFebruary 8, 2024
K222245biomaterials koreaACR Screw SystemAugust 21, 2023
K202163ze fang technology coMico One Orthodontic ScrewOctober 7, 2022
K202691craniofacial technologiesOrtholock Anchorage DevicesApril 28, 2022
K210559mk meditechATOZ Mini-ScrewDecember 19, 2021
K211992osteonic coOrtho MI SystemOctober 15, 2021
K202790syntec scientific corporationSyntec Orthodontic Mini Screw Extended SystemSeptember 17, 2021
K202278bomei coOBS Anchorage Screw, Biokey Anchorage ScrewJanuary 8, 2021
K201919blue sky bioBlue Sky Bio TADDecember 17, 2020
K191041gni coOrthodontic Fixation Screw [Smart Anchor Miniscrew]August 28, 2020
K190871biocetec coBio-TackS Orthodontic Mini ImplantJanuary 17, 2020
K182929microware precision coBIO-RAY A-1 Anchor Screw SystemNovember 6, 2019
K181142dentosAbsoanchor MicroimplantFebruary 5, 2019
K173623biomaterials koreaAnchor plateAugust 30, 2018
K161335jeil medical corporationDual Top Screw SystemFebruary 23, 2017
K161197osstem implant coOrthodontic ScrewDecember 21, 2016
K152297bomei coOBS Anchorage ScrewFebruary 9, 2016
K142001syntec scientific corporation - taipei officeSYNTEC WETALI ORTHODONTIC MINI SCREWSMarch 18, 2015