FDA 510(k)

Straumann骨水平锥形植入体

K号: K153758 · 2016-03-23

决定日期2016-03-23

产品代码DZE

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决定实质等同

器械摘要

Straumann Bone Level Tapered Implants is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K153758. 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 Straumann Bone Level Tapered Implants?

Straumann Bone Level Tapered Implants is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Institut Straumann AG. The 510(k) number is K153758.

When did Straumann Bone Level Tapered Implants receive FDA 510(k) clearance?

Straumann Bone Level Tapered Implants received FDA 510(k) clearance on 2016-03-23, under 510(k) number K153758.

Who is the listed applicant for Straumann Bone Level Tapered Implants?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann Bone Level Tapered Implants?

The FDA product code for Straumann Bone Level Tapered Implants is DZE.

列明Institut Straumann AG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。

K260726Straumann® ProClean™托盘（041.800；041.801）K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue K252168Straumann® BLC植入物 - 指征扩大 K253315Straumann Variobase 基台 XC 用于桥/杆 K250294Straumann® RidgeFit植入物 K243278定制基台

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官方来源

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