OAT
- Product code
- OAT
- Device name
- Implant, Endosseous, Orthodontic
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3640
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 52 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260268 | 2026-05-19 | Bernhard Förster GmbH (Bernhard Foerst… | OrthoEasy Pal; OrthoEasy Pal Long Neck | |
| K242944 | 2025-06-19 | Leone S.P.A. | Leone Orthodontic Implant TAD (Temporary Anchorage D… | |
| K231502 | 2024-09-04 | Proimtech Saglik Urunleri Anonim Sirke… | Mini Screws | |
| K231913 | 2024-02-08 | Techwin Co., Ltd. | T-FIT |
Official FDA classification page: OAT
Classification and pathway per current FDA publications. Data from openFDA (CC0).