FDA 510(k)

Implantswiss 牙齿种植系统，Implantswiss 牙齿种植体连接系统

K号: K181266 · 2018-11-01

决定日期2018-11-01

产品代码DZE

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决定实质等同

器械摘要

Implantswiss Dental Implant System, Implantswiss Dental Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Novodent SA. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K181266. 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 Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

Implantswiss Dental Implant System, Implantswiss Dental Abutment System is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Novodent SA. The 510(k) number is K181266.

When did Implantswiss Dental Implant System, Implantswiss Dental Abutment System receive FDA 510(k) clearance?

Implantswiss Dental Implant System, Implantswiss Dental Abutment System received FDA 510(k) clearance on 2018-11-01, under 510(k) number K181266.

Who is the listed applicant for Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

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

What is the FDA product code for Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

The FDA product code for Implantswiss Dental Implant System, Implantswiss Dental Abutment System is DZE.

列明Novodent SA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。

K200867Implantswiss 牙齿种植系统及 Implantswiss 牙齿种植体连接系统

官方来源

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