FDA 510(k)

Nobel Biocare 牙齿种植系统组合 - MR 条件

K号: K212125 · 2021-09-24

决定日期2021-09-24

产品代码DZE

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决定实质等同

器械摘要

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AG. It received FDA 510(k) clearance on 2021-09-24 under 510(k) number K212125. 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 Nobel Biocare Dental Implant Systems Portfolio - MR Conditional?

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Nobel Biocare AG. The 510(k) number is K212125.

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

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212125.

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

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

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

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

列明Nobel Biocare 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。

K200040通用锥形连接器（CC）

官方来源

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