FDA 510(k)

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

Número K: K242944 · 2025-06-19

Data da decisão2025-06-19

Código do produtoOAT

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: OAT)

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K231502Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi K231913T-FITTechwin Co., Ltd.K222245Sistema de Parafuso ACRBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.K202691Ortholock Anchorage DevicesCraniofacial Technologies, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.