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FDA 510(k)

Centrix FluoroSilver银氟化物38%

K号: K222459 · 2023-10-27

申请人Centrix, Inc.
决定日期2023-10-27
产品代码PHR
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决定实质等同

器械摘要

Centrix FluoroSilver Silver Diamine Fluoride 38% is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K222459. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Centrix FluoroSilver Silver Diamine Fluoride 38%?

Centrix FluoroSilver Silver Diamine Fluoride 38% is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Centrix, Inc.. The 510(k) number is K222459.

When did Centrix FluoroSilver Silver Diamine Fluoride 38% receive FDA 510(k) clearance?

Centrix FluoroSilver Silver Diamine Fluoride 38% received FDA 510(k) clearance on 2023-10-27, under 510(k) number K222459.

Who is the listed applicant for Centrix FluoroSilver Silver Diamine Fluoride 38%?

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

What is the FDA product code for Centrix FluoroSilver Silver Diamine Fluoride 38%?

The FDA product code for Centrix FluoroSilver Silver Diamine Fluoride 38% is PHR.

相关临床试验

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列明Centrix, 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。

相关器械(代码:PHR)

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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