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510(k) K253816

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

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.

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