FDA 510(k)

Zeramex P6 牙种植系统

K号: K163043 · 2016-11-30

决定日期2016-11-30

产品代码DZE

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决定实质等同

器械摘要

Zeramex P6 Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dentalpoint AG. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K163043. 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 Zeramex P6 Dental Implant System?

Zeramex P6 Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Dentalpoint AG. The 510(k) number is K163043.

When did Zeramex P6 Dental Implant System receive FDA 510(k) clearance?

Zeramex P6 Dental Implant System received FDA 510(k) clearance on 2016-11-30, under 510(k) number K163043.

Who is the listed applicant for Zeramex P6 Dental Implant System?

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

What is the FDA product code for Zeramex P6 Dental Implant System?

The FDA product code for Zeramex P6 Dental Implant System is DZE.

列明Dentalpoint 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。

K180184Zeramex(R) XT 牙齿种植系统，NobelPearl 牙齿种植系统 K152385Zeramex P6 牙种植系统

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。