FDA 510(k)

Silatrix 口腔凝胶

K号: K252425 · 2025-10-23

决定日期2025-10-23

产品代码OLR

决定实质等同

器械摘要

Silatrix Oral Gel is the device name listed in this FDA 510(k) record. The listed applicant is Sa3, LLC. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K252425. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

常见问题

What is the Silatrix Oral Gel?

Silatrix Oral Gel is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Sa3, LLC. The 510(k) number is K252425.

When did Silatrix Oral Gel receive FDA 510(k) clearance?

Silatrix Oral Gel received FDA 510(k) clearance on 2025-10-23, under 510(k) number K252425.

Who is the listed applicant for Silatrix Oral Gel?

The FDA 510(k) record lists Sa3, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silatrix Oral Gel?

The FDA product code for Silatrix Oral Gel is OLR.

列明Sa3, 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。

K202000Silatrix 口腔凝胶

官方来源

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