FDA 510(k)

银氟化物过敏漆

K号: K241041 · 2025-02-28

申请人Young Dental Manufacturing Co. 1, LLC

决定日期2025-02-28

产品代码PHR

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决定实质等同

器械摘要

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.

常见问题

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.

列明Young Dental Manufacturing Co. 1, 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。

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