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.

Summary

MoleculeX filed the MuCover Oral Wound Dressing under OLR, oral wound dressings. The device name in the record includes "(proposed name)" after MuCover.

Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).

MoleculeX filed from Hsinchu, Taiwan. The decision came 174 calendar days after receipt (November 28, 2025 to May 21, 2026).

Clearance details

Applicant: MoleculeX Co., Ltd.
Product code: Product 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

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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.