MuCover (proposed name) Oral Wound Dressing
FDA 510(k) K253816 · MoleculeX Co., Ltd.
510(k) numberK253816
Submission
- Device name
- MuCover (proposed name) Oral Wound Dressing
- Applicant
- MoleculeX Co., Ltd.
Hsinchu, TW - Received
- November 28, 2025
- Decision date
- May 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLR – Oral Wound Dressing
- Device class
- Unclassified
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
Other 510(k)s with product code OLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260120 | NaturaJel Oral Wound Care KitOLR · Traditional | HCS Innovation, LLC | 08/05/2026SE |
| K251908 | Emanate TrayOLR · Traditional | Emanate Biomedical | 07/29/2026SE |
| K260126 | Curajel Oral GelOLR · Traditional | USpharma, Ltd. | 06/15/2026SE |
| K253758 | Dental Cone; Dental SpongeOLR · Special | Medizin Produkte Neustadt GmbH (Mpn) | 12/18/2025SE |
| K252425 | Silatrix Oral GelOLR · Traditional | Sa3, LLC | 10/23/2025SE |
| K241283 | Elemental GranulateOLR · Traditional | Zinkh NV | 01/03/2025SE |
| K230529 | HealiAid Dental Collagen Wound DressingOLR · Traditional | Maxigen Biotech, Inc. | 11/22/2023SE |
| K221428 | PerioStom Dental DressingOLR · Traditional | Forward Science, LLC | 12/22/2022SE |
| K211851 | Ora-AidOLR · Traditional | Tbm Corporation | 01/11/2022SE |
| K210211 | PuraStat-OMOLR · Traditional | 3-D Matrix, Inc. | 10/08/2021SE |
Questions and answers
When was MuCover (proposed name) Oral Wound Dressing cleared by the FDA?
MuCover (proposed name) Oral Wound Dressing (K253816) received a 510(k) decision of Substantially Equivalent on May 21, 2026, 174 days after the submission was received.
What is the product code of K253816?
The FDA product code is OLR – Oral Wound Dressing, a Unclassified device.