Leone正畸植入体TAD（临时锚定装置）
K号: K242944 · 2025-06-19
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申请人Leone S.P.A.
决定日期2025-06-19
产品代码OAT
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OAT）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K231502微型螺丝Proimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR 螺丝系统Biomaterials Korea, Inc.K202163Mico One 正畸螺丝Ze Fang Technology Co., Ltd.K202691Ortholock 锚定装置Craniofacial Technologies, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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