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FDA 510(k)

OverCEM SA通用；OverCEM SA透明；OverCEM SA不透明；OverCEM Ti-牙槽；OverCEM Cer-牙槽

K号: K242366 · 2025-01-10

申请人Overfibers S.R.L.
决定日期2025-01-10
产品代码EMA
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决定实质等同

器械摘要

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Overfibers S.R.L.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K242366. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Overfibers S.R.L.. The 510(k) number is K242366.

When did OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment receive FDA 510(k) clearance?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242366.

Who is the listed applicant for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA 510(k) record lists Overfibers S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is EMA.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：EMA）

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。

K262983EsTemp植入物Spident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN生物活性水泥Inter-Med, Inc.

官方来源

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