FDA 510(k)

Silatrix Oral Gel

K-Number: K202000 · 2020-11-20

Decision Date2020-11-20

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

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 2020-11-20 under 510(k) number K202000. 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 2020-11-20. The listed applicant is Sa3, LLC. The 510(k) number is K202000.

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

Silatrix Oral Gel received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202000.

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.

Other records listing Sa3, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252425Silatrix Oral Gel

Related Devices (Code: OLR)

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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.