FDA 510(k)

Centrix FluoroSilver Silver Diamine Fluoride 38%

K 號：K222459 · 2023-10-27

決定日期2023-10-27

產品代碼PHR

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Centrix, Inc. 為申請人之記錄

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相關器械（代碼：PHR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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