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FDA 510(k)

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

K-Number: K242944 · 2025-06-19

ApplicantLeone S.P.A.
Decision Date2025-06-19
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Leone Orthodontic Implant TAD (Temporary Anchorage Device) is a medical device manufactured by Leone S.P.A.. It received FDA 510(k) clearance on 2025-06-19 under approval number K242944. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leone Orthodontic Implant TAD (Temporary Anchorage Device)?

Leone Orthodontic Implant TAD (Temporary Anchorage Device) is a medical device that received FDA 510(k) clearance on 2025-06-19. It is manufactured by Leone S.P.A.. The 510(k) number is K242944.

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

Leone Orthodontic Implant TAD (Temporary Anchorage Device) received FDA 510(k) clearance on 2025-06-19, under approval number K242944.

What company makes Leone Orthodontic Implant TAD (Temporary Anchorage Device)?

Leone Orthodontic Implant TAD (Temporary Anchorage Device) is manufactured by Leone S.P.A..

What is the FDA product code for Leone Orthodontic Implant TAD (Temporary Anchorage Device)?

The FDA product code for Leone Orthodontic Implant TAD (Temporary Anchorage Device) is OAT.

Related Clinical Trials

NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT06859970 An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure ACTIVE_NOT_RECRUITING NCT07343141 To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds NOT_YET_RECRUITING NCT05147792 The CONFORM Pivotal Trial RECRUITING NCT04012944 SIRONA 2 Trial Heart Failure NYHA Class III ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 41966215 Advancing Public Health Through Internationally Coordinated Medical Device Registries Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2026) PMID: 39973146 Characterization of Spine Implant Device Recalls: A 21-Year Analysis. Spine (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd. K181142Absoanchor MicroimplantDentos, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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