Silatrix Oral Gel— 510(k) K202000

Name: FDA 510(k) clearance K202000
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Substantially Equivalent

Sa3, LLC

FDA 510(k) clearance K202000 for Silatrix Oral Gel, Substantially Equivalent on 2020-11-20. Applicant: Sa3, LLC. Device class: Unclassified.

Clearance details

Applicant: Sa3, LLC
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-07-20
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

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K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18

More clearances from Sa3, LLC

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K252425 — Silatrix Oral Gel2025-10-23

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K202000

K-number listed on FDA's recall record

Z-0856-2022 — Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gmClass II·Terminated·SA3, LLC·20220221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202000.

Data sourced from openFDA. This site is unofficial and independent of the FDA.