FDA 510(k)

BTI 牙齿种植系统 UnicCa® - 美学基桩

K号: K231827 · 2023-09-15

决定日期2023-09-15

产品代码NHA

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决定实质等同

器械摘要

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments 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 2023-09-15 under 510(k) number K231827. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K231827.

When did BTI Dental Implant System UnicCa® – Aesthetic Post Abutments receive FDA 510(k) clearance?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments received FDA 510(k) clearance on 2023-09-15, under 510(k) number K231827.

Who is the listed applicant for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

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 Dental Implant System UnicCa® – Aesthetic Post Abutments?

The FDA product code for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is NHA.

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。

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相关器械（代码：NHA）

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。

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