OATClass II

Implant, Endosseous, Orthodontic

21 CFR 872.3640 / Dental

OAT is the FDA product code for Implant, Endosseous, Orthodontic, a class II device type, regulated under 21 CFR 872.3640. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 52 510(k) clearances under this code, the most recent dated 2026-05-19, and 3 recalls.

Classification record

Product code: OAT
Device name: Implant, Endosseous, Orthodontic
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.
Regulation: 21 CFR 872.3640
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 52
Ingested recalls: 3

Clearances, product code OAT

By decision year

52 clearances under product code OAT with a decision year between 1998 and 2026, 2006 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code OAT by decision year
Year	Clearances
1998	1
2004	1
2005	1
2006	6
2007	6
2008	3
2009	2
2010	2
2011	5
2012	1
2013	2
2014	1
2015	1
2016	2
2017	1
2018	1
2019	2
2020	3
2021	4
2022	2
2023	1
2024	2
2025	1
2026	1

Applicants with the most clearances

Product code OAT

Applicants holding the most 510(k) clearances under product code OAT
Applicant	Clearances
Biomaterials Korea Inc.	4
Dentaurum Inc.	3
Straumann USA, LLC	3
Bomei Co., Ltd.	2
D B Orthodontics Ltd	2
OSSTEM Implant Co., Ltd.	2
Syntec Scientific Corp.	2
Synthes (USA) Products LLC	2
Ace Surgical Supply Co., Inc.	1
Alpha-Bio Tec	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order