FDA 510(k)

现有 Straumann 牙种植系统兼容 MRI

K号: K190662 · 2019-06-17

决定日期2019-06-17

产品代码DZE

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决定实质等同

器械摘要

MRI Compatibility for Existing Straumann Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K190662. 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 MRI Compatibility for Existing Straumann Dental Implant Systems?

MRI Compatibility for Existing Straumann Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Straumann USA, LLC. The 510(k) number is K190662.

When did MRI Compatibility for Existing Straumann Dental Implant Systems receive FDA 510(k) clearance?

MRI Compatibility for Existing Straumann Dental Implant Systems received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190662.

Who is the listed applicant for MRI Compatibility for Existing Straumann Dental Implant Systems?

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

What is the FDA product code for MRI Compatibility for Existing Straumann Dental Implant Systems?

The FDA product code for MRI Compatibility for Existing Straumann Dental Implant Systems is DZE.

列明Straumann USA, LLC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。

K241575Straumann® 解剖愈合基台 XC (AHA)K203753Straumann 外科托盘 K202942Straumann 4 毫米短植入体 K192401Straumann 螺丝固定基台 K171784Straumann牙种植系统 K162890BLT 02.9mm SC, SLA 或 SLActive, RXD, Loxim, SC Closure Cap 和愈合基台, SC 临时基台, SC Variobase 基台, SC CARES 基台

查看所有 8 个设备 →

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。