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FDA 510(k)

MuCover (proposed name) Oral Wound Dressing

K-Number: K253816 · 2026-05-21

ApplicantMoleculeX Co., Ltd.
Decision Date2026-05-21
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

MuCover (proposed name) Oral Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is MoleculeX Co., Ltd.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253816. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MuCover (proposed name) Oral Wound Dressing?

MuCover (proposed name) Oral Wound Dressing is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is MoleculeX Co., Ltd.. The 510(k) number is K253816.

When did MuCover (proposed name) Oral Wound Dressing receive FDA 510(k) clearance?

MuCover (proposed name) Oral Wound Dressing received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253816.

Who is the listed applicant for MuCover (proposed name) Oral Wound Dressing?

The FDA 510(k) record lists MoleculeX Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MuCover (proposed name) Oral Wound Dressing?

The FDA product code for MuCover (proposed name) Oral Wound Dressing is OLR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06150326Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.RECRUITINGNCT06960161Exploring the Use of Phototherapy to Improve CPAP ComplianceRECRUITINGNCT07409571Palatal Wound Healing After Free Gingival Graft SurgeryRECRUITINGNCT07522684Polynucleotide + Hyaluronic Acid Gel With Xenogeneic Graft for Intrabony Periodontal DefectsRECRUITINGNCT07523802Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal StentRECRUITINGNCT07613775Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival RecessionsNOT_YET_RECRUITING

Related Devices (Code: OLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLCK241283Elemental GranulateZinkh NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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