FDA 510(k)

矽膠口腔膠

K 號：K252425 · 2025-10-23

決定日期2025-10-23

產品代碼OLR

決定相當於

器材摘要

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.

常見問題

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.

其他以 Sa3, LLC 為申請人之記錄

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K202000矽膠口腔膠

相關器械（代碼：OLR）

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。

K260120NaturaJel™ 口腔傷口護理套件HCS Innovation, LLC K251908發射盤Emanate Biomedical K260126Curajel™ 口腔膠USpharma, Ltd.K253816MuCover（建議名稱）口內傷口敷料MoleculeX Co., Ltd.K253758牙科擴散器；牙科濕巾Medizin Produkte Neustadt GmbH (Mpn)K241283元素顆粒Zinkh NV

官方來源

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