Leone Orthodontic Implant TAD (Temporary Anchorage Device)

FDA 510(k) K242944 · Leone S.P.A.

Substantially Equivalent

510(k) numberK242944

Submission

Device name
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
Applicant
Leone S.P.A.
Sesto Fiorentino, IT
Received
September 25, 2024
Decision date
June 19, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAT – Implant, Endosseous, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

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.

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K260268OrthoEasy Pal; OrthoEasy Pal Long NeckOAT · Traditional Bernhard Förster GmbH (Bernhard Foerster Ltd.)05/19/2026SE
K231502Mini ScrewsOAT · Traditional Proimtech Saglik Urunleri Anonim Sirketi09/04/2024SE
K231913T-FitOAT · Traditional Techwin Co., Ltd.02/08/2024SE
K222245ACR Screw SystemOAT · Traditional Biomaterials Korea, Inc.08/21/2023SE
K202163Mico One Orthodontic ScrewOAT · Traditional Ze Fang Technology Co., Ltd.10/07/2022SE
K202691Ortholock Anchorage DevicesOAT · Traditional Craniofacial Technologies, Inc.04/28/2022SE
K210559ATOZ Mini-ScrewOAT · Traditional Mk Meditech, Inc.12/19/2021SE
K211992Ortho MI SystemOAT · Traditional Osteonic Co., Ltd.10/15/2021SE
K202790Syntec Orthodontic Mini Screw Extended SystemOAT · Special Syntec Scientific Corporation09/17/2021SE
K202278OBS Anchorage Screw, Biokey Anchorage ScrewOAT · Special Bomei Co, Ltd.01/08/2021SE

More from Bomei Co, Ltd.

510(k)DeviceDecision
K071490Leone Orthodontic Mini ImplantOAT · Traditional 02/22/2008SE
K070483Leone Monoimplant for O-Ring OverdentureDZE · Traditional 04/19/2007SE
K050586Leone Implant SystemDZE · Abbreviated 02/27/2006SE

Questions and answers

When was Leone Orthodontic Implant TAD (Temporary Anchorage Device) cleared by the FDA?

Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944) received a 510(k) decision of Substantially Equivalent on June 19, 2025, 267 days after the submission was received.

What is the product code of K242944?

The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.