FDA 510(k)

Implant Direct 牙齿植入系统组合 - MR 条件

K号: K222211 · 2023-02-02

申请人Implant Direct Sybron Manufacturing, LLC

决定日期2023-02-02

产品代码DZE

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决定实质等同

器械摘要

Implant Direct Dental Implant Systems Portfolio - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K222211. 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 Implant Direct Dental Implant Systems Portfolio - MR Conditional?

Implant Direct Dental Implant Systems Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K222211.

When did Implant Direct Dental Implant Systems Portfolio - MR Conditional receive FDA 510(k) clearance?

Implant Direct Dental Implant Systems Portfolio - MR Conditional received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222211.

Who is the listed applicant for Implant Direct Dental Implant Systems Portfolio - MR Conditional?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant Direct Dental Implant Systems Portfolio - MR Conditional?

The FDA product code for Implant Direct Dental Implant Systems Portfolio - MR Conditional is DZE.

列明Implant Direct Sybron Manufacturing, 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。

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