K202000 - Silatrix Oral Gel (FDA 510(k) Clearance)

K202000 is an FDA 510(k) clearance for the Silatrix Oral Gel. Classified as Oral Wound Dressing (product code OLR).

Submitted by Sa3, LLC (Los Angeles, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 123 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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