Cleared Traditional

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

K202000 · Sa3, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
123d
Days
-
Risk

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.

View all Sa3, LLC devices

Submission Details

510(k) Number K202000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2020
Decision Date November 20, 2020
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 13
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K202000.
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021
MucoLock Oral Gel
K203091 · Pcca, Inc. · Feb 2021
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
K193336 · Synedgen, Inc. · May 2020
Orapeutic
K191987 · Forward Science · Nov 2019
OraCure
K183436 · Tbm Corporation · Sep 2019