FDA 510(k)

Atlantis 上部结构

K号: K193064 · 2020-03-03

决定日期2020-03-03

产品代码NHA

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决定实质等同

器械摘要

Atlantis suprastructures is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2020-03-03 under 510(k) number K193064. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atlantis suprastructures?

Atlantis suprastructures is a medical device that received FDA 510(k) clearance on 2020-03-03. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K193064.

When did Atlantis suprastructures receive FDA 510(k) clearance?

Atlantis suprastructures received FDA 510(k) clearance on 2020-03-03, under 510(k) number K193064.

Who is the listed applicant for Atlantis suprastructures?

FDA 510(k)记录中列出Dentsply Sirona, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Atlantis suprastructures?

The FDA product code for Atlantis suprastructures is NHA.

列明Dentsply Sirona, Inc.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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相关器械（代码：NHA）

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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