FDA product code OAT: Implant, Endosseous, Orthodontic
OAT is the FDA product code for implant, endosseous, orthodontic. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel. FDA has cleared 52 510(k) submissions under OAT, 7 in the last five years, from 43 different applicants. The average 510(k) review took 215 days (median 165); 241 days on average over the last three years. FDA has posted 3 recalls for OAT devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Endosseous, Orthodontic |
| Device class | Class II |
| Regulation | 21 CFR 872.3640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OAT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 287 |
| 2018 | 1 | 279 |
| 2019 | 2 | 330 |
| 2020 | 3 | 315 |
| 2021 | 4 | 229 |
| 2022 | 2 | 692 |
| 2023 | 1 | 391 |
| 2024 | 2 | 346 |
| 2025 | 1 | 267 |
| 2026 | 1 | 111 |
Compare with all 510(k) review times · Search every OAT clearance
Top OAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomaterials Korea, Inc. | 4 | 2023-08-21 |
| Leone S.P.A. | 2 | 2025-06-19 |
| Bomei Co, Ltd. | 2 | 2021-01-08 |
| Osstem Implant Co., Ltd. | 2 | 2016-12-21 |
| Synthes (Usa) | 2 | 2010-12-16 |
38 more applicants have OAT clearances. See the full list in Caduvo.
Most recent OAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260268 | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | OrthoEasy Pal; OrthoEasy Pal Long Neck | 2026-05-19 | 111 |
| K242944 | Leone S.P.A. | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | 2025-06-19 | 267 |
| K231502 | Proimtech Saglik Urunleri Anonim Sirketi | Mini Screws | 2024-09-04 | 469 |
| K231913 | Techwin Co., Ltd. | T-FIT | 2024-02-08 | 224 |
| K222245 | Biomaterials Korea, Inc. | ACR Screw System | 2023-08-21 | 391 |
Recalls for OAT devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-07-12.
Frequently asked questions
What is FDA product code OAT?
OAT is the FDA product code for implant, endosseous, orthodontic. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel.
What device class is OAT?
Class II, regulation 21 CFR 872.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAT?
Across 52 cleared submissions the average was 215 days from receipt to decision (median 165).
Which companies have the most OAT clearances?
Biomaterials Korea, Inc. (4); Leone S.P.A. (2); Bomei Co, Ltd. (2); Osstem Implant Co., Ltd. (2); Synthes (Usa) (2).
Have OAT devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2013-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OAT
- Run a recall and safety report across every OAT manufacturer
- Watch product code OAT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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