MuCover (proposed name) Oral Wound Dressing— 510(k) K253816

Name: FDA 510(k) clearance K253816
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Substantially Equivalent

MoleculeX Co., Ltd.

FDA 510(k) clearance K253816 for MuCover (proposed name) Oral Wound Dressing, Substantially Equivalent on 2026-05-21. Applicant: MoleculeX Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: MoleculeX Co., Ltd.
Product code: Code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-11-28
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

view all

K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K260126 — Curajel Oral Gel2026-06-15
K253758 — Dental Cone; Dental Sponge2025-12-18
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 →

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