FDA 510(k)

MOR 3.0mm和PUR NP 3.2mm植入系统，MOR 2.1x18mm和2.4x18mm

K号: K171728 · 2017-09-28

决定日期2017-09-28

产品代码DZE

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决定实质等同

器械摘要

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold Dental, LLC. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K171728. 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 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Sterngold Dental, LLC. The 510(k) number is K171728.

When did MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm receive FDA 510(k) clearance?

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm received FDA 510(k) clearance on 2017-09-28, under 510(k) number K171728.

Who is the listed applicant for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

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

What is the FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm?

The FDA product code for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm is DZE.

列明Sterngold Dental, LLC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。

K153173MOR植入系统

官方来源

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