FDA 510(k)

Kontact 牙齿种植系统

K号: K213997 · 2022-07-15

决定日期2022-07-15

产品代码DZE

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决定实质等同

器械摘要

Kontact Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Dental, Sas. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K213997. 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 Kontact Dental Implant System?

Kontact Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Biotech Dental, Sas. The 510(k) number is K213997.

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

Kontact Dental Implant System received FDA 510(k) clearance on 2022-07-15, under 510(k) number K213997.

Who is the listed applicant for Kontact Dental Implant System?

The FDA 510(k) record lists Biotech Dental, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kontact Dental Implant System?

The FDA product code for Kontact Dental Implant System is DZE.

列明Biotech Dental, Sas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。

K212068Biotech 牙科工具包 K210220Kontact 牙齿种植系统

官方来源

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