Cleared Traditional

K252425 - Silatrix Oral Gel (FDA 510(k) Clearance)

K252425 · Sa3, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
83d
Days
-
Risk

K252425 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 October 23, 2025 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sa3, LLC devices

Submission Details

510(k) Number K252425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date October 23, 2025
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 Consultant

Eliquent Life Sciences, Inc.
Mark Kramer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLR Oral Wound Dressing

All 38
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K252425.
Dental Cone
K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dec 2025
Elemental Granulate
K241283 · Zinkh NV · Jan 2025
HealiAid Dental Collagen Wound Dressing
K230529 · Maxigen Biotech, Inc. · Nov 2023
PerioStom Dental Dressing
K221428 · Forward Science, LLC · Dec 2022
Ora-Aid
K211851 · Tbm Corporation · Jan 2022
PuraStat-OM
K210211 · 3-D Matrix, Inc. · Oct 2021