FDA 510(k)

NUVENTUS NV.C® 牙齿种植系统

K号: K233081 · 2024-11-15

决定日期2024-11-15

产品代码DZE

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决定实质等同

器械摘要

NUVENTUS NV.C™ Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K233081. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NUVENTUS NV.C™ Dental Implant System?

NUVENTUS NV.C™ Dental Implant System is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K233081.

When did NUVENTUS NV.C™ Dental Implant System receive FDA 510(k) clearance?

NUVENTUS NV.C™ Dental Implant System received FDA 510(k) clearance on 2024-11-15, under 510(k) number K233081.

Who is the listed applicant for NUVENTUS NV.C™ Dental Implant System?

The FDA 510(k) record lists Infinitum Eta, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVENTUS NV.C™ Dental Implant System?

The FDA product code for NUVENTUS NV.C™ Dental Implant System is DZE.

列明Infinitum Eta, Ltd.为申报人的其他记录

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。

K251220NUVENTUS NV.C® 假肢组件 K243317NUVENTUS NV.C® 外科托盘和托盘

官方来源

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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。