OAT

Implant, Endosseous, Orthodontic

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-05-19.

NumberDecision dateApplicantDevice nameSummary
K2602682026-05-19Bernhard Förster GmbH (Bernhard Foerst…OrthoEasy Pal; OrthoEasy Pal Long NeckPDF
K2429442025-06-19Leone S.P.A.Leone Orthodontic Implant TAD (Temporary Anchorage D…PDF
K2315022024-09-04Proimtech Saglik Urunleri Anonim Sirke…Mini ScrewsPDF
K2319132024-02-08Techwin Co., Ltd.T-FITPDF

4 summaries are archived here for direct download.

Official FDA classification page: OAT
Classification and pathway per current FDA publications. Data from openFDA (CC0).