FDA 510(k)

BTI Interna 3.0 牙齿种植系统 UnicCa®

K号: K240262 · 2024-10-10

决定日期2024-10-10

产品代码DZE

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决定实质等同

器械摘要

BTI Interna 3.0 Dental Implant System UnicCa® is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K240262. 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 BTI Interna 3.0 Dental Implant System UnicCa®?

BTI Interna 3.0 Dental Implant System UnicCa® is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K240262.

When did BTI Interna 3.0 Dental Implant System UnicCa® receive FDA 510(k) clearance?

BTI Interna 3.0 Dental Implant System UnicCa® received FDA 510(k) clearance on 2024-10-10, under 510(k) number K240262.

Who is the listed applicant for BTI Interna 3.0 Dental Implant System UnicCa®?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Interna 3.0 Dental Implant System UnicCa®?

The FDA product code for BTI Interna 3.0 Dental Implant System UnicCa® is DZE.

列明B.T.I. Biotechnology Institute, Sl.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。

K232750BTI Interna 假体组件 K231827BTI 牙齿种植系统 UnicCa® - 美学基桩 K213106BTI Interna 牙齿种植系统 UnicCa - 假体组件 K211952BTI Interna 窄/Plus 牙齿种植系统 UnicCa K202825BTI 长短牙种植系统 UnicCa K173257BTI 牙齿种植系统 UnicCa

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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。