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FDA 510(k)

Silatrix Oral Gel

K-Number: K252425 · 2025-10-23

ApplicantSa3, LLC
Decision Date2025-10-23
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

Silatrix Oral Gel is a medical device manufactured by Sa3, LLC. It received FDA 510(k) clearance on 2025-10-23 under approval number K252425. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silatrix Oral Gel?

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

When was Silatrix Oral Gel approved by the FDA?

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

What company makes Silatrix Oral Gel?

Silatrix Oral Gel is manufactured by Sa3, LLC.

What is the FDA product code for Silatrix Oral Gel?

The FDA product code for Silatrix Oral Gel is OLR.

Other Devices by Sa3, LLC

K202000Silatrix Oral Gel

Related Devices (Code: OLR)

K173196SUNTOUCH Dental DressingHuizhou Foryou Medical Devices Co., Ltd. K191987OrapeuticForward Science K183436OraCureTbm Corporation K202000Silatrix Oral GelSa3, LLC K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseSynedgen, Inc. K210211PuraStat-OM3-D Matrix, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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