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510(k) K253816

MuCover (proposed name) Oral Wound Dressing by MoleculeX Co., Ltd. — Product Code OLR

K253816 is an FDA 510(k) premarket notification submitted by MoleculeX Co., Ltd. for the device "MuCover (proposed name) Oral Wound Dressing". The FDA issued a decision of Substantially Equivalent on May 21, 2026. The device falls under product code OLR (Oral Wound Dressing), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2026
Date Received
November 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Other clearances for product code OLR

  • K260126 — Curajel™ Oral Gel (June 15, 2026)
  • K253758 — Dental Cone; Dental Sponge (December 18, 2025)
  • K252425 — Silatrix Oral Gel (October 23, 2025)
  • K241283 — Elemental Granulate (January 3, 2025)
  • K230529 — HealiAid Dental Collagen Wound Dressing (November 22, 2023)
  • K221428 — PerioStom Dental Dressing (December 22, 2022)
  • K211851 — Ora-Aid (January 11, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K203091 — MucoLock Oral Gel (February 12, 2021)
  • K202000 — Silatrix Oral Gel (November 20, 2020)

FDA data resources