FDA 510(k)

銀鹵化物過敏性膠漆

K 號：K241041 · 2025-02-28

申請人Young Dental Manufacturing Co. 1, LLC

決定日期2025-02-28

產品代碼PHR

諮詢委員會DE

決定相當於

器材摘要

Silver Fluoride Hypersensitivity Varnish is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241041. 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 Silver Fluoride Hypersensitivity Varnish?

Silver Fluoride Hypersensitivity Varnish is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K241041.

When did Silver Fluoride Hypersensitivity Varnish receive FDA 510(k) clearance?

Silver Fluoride Hypersensitivity Varnish received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241041.

Who is the listed applicant for Silver Fluoride Hypersensitivity Varnish?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silver Fluoride Hypersensitivity Varnish?

The FDA product code for Silver Fluoride Hypersensitivity Varnish is PHR.

其他以 Young Dental Manufacturing Co. 1, LLC 為申請人之記錄

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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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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