OLR
- Product code
- OLR
- Device name
- Oral Wound Dressing
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 43
FDA classification definition
Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260120 | 2026-08-05 | HCS Innovation, LLC | NaturaJel Oral Wound Care Kit | |
| K251908 | 2026-07-29 | Emanate Biomedical | Emanate Tray | |
| K260126 | 2026-06-15 | USpharma, Ltd. | Curajel Oral Gel | |
| K253816 | 2026-05-21 | MoleculeX Co., Ltd. | MuCover (proposed name) Oral Wound Dressing | |
| K253758 | 2025-12-18 | Medizin Produkte Neustadt GmbH (Mpn) | Dental Cone; Dental Sponge | |
| K252425 | 2025-10-23 | Sa3, LLC | Silatrix Oral Gel | |
| K241283 | 2025-01-03 | Zinkh NV | Elemental Granulate | |
| K230529 | 2023-11-22 | Maxigen Biotech, Inc. | HealiAid Dental Collagen Wound Dressing |
Official FDA classification page: OLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).