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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 the device name listed in this FDA 510(k) record. The listed applicant is Leone S.P.A.. It received FDA 510(k) clearance on 2025-06-19 under 510(k) 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. The listed applicant is Leone S.P.A.. The 510(k) number is K242944.

When did Leone Orthodontic Implant TAD (Temporary Anchorage Device) receive FDA 510(k) clearance?

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

Who is the listed applicant for Leone Orthodontic Implant TAD (Temporary Anchorage Device)?

The FDA 510(k) record lists Leone S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04419805Single Palatal Temporary Anchorage Device for Anterior Open BiteACTIVE_NOT_RECRUITINGNCT07715851Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion TechniquesNOT_YET_RECRUITINGNCT07780149Maximum Clinical Insertion Torque and Its Association With the Success Rate of Orthodontic MiniscrewsCOMPLETED

Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.K202691Ortholock Anchorage DevicesCraniofacial Technologies, 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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