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FDA 510(k)

ATLANTIS Abutment for HIOSSEN ET implant

K号: K160626 · 2016-08-29

决定日期2016-08-29
产品代码NHA
咨询委员会DE
决定Substantially Equivalent

器械摘要

ATLANTIS Abutment for HIOSSEN ET implant is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K160626. 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 Abutment for HIOSSEN ET implant?

ATLANTIS Abutment for HIOSSEN ET implant is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Dentsply Sirona. The 510(k) number is K160626.

When did ATLANTIS Abutment for HIOSSEN ET implant receive FDA 510(k) clearance?

ATLANTIS Abutment for HIOSSEN ET implant received FDA 510(k) clearance on 2016-08-29, under 510(k) number K160626.

Who is the listed applicant for ATLANTIS Abutment for HIOSSEN ET implant?

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

What is the FDA product code for ATLANTIS Abutment for HIOSSEN ET implant?

The FDA product code for ATLANTIS Abutment for HIOSSEN ET implant is NHA.

相关临床试验

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列明Dentsply Sirona为申报人的其他记录

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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。

官方来源

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