NaturaJel™ Oral Wound Care Kit
FDA 510(k) clearance K260120 · decided 2026-08-05
Clearance details
- K-number
- K260120
- Device name
- NaturaJel™ Oral Wound Care Kit
- Applicant
- HCS Innovation, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-01-15
- Decision date
- 2026-08-05
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Union Grove, AL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Emanate Tray (K251908) | Emanate Biomedical | 2026-07-29 |
| Curajel™ Oral Gel (K260126) | USpharma, Ltd. | 2026-06-15 |
| MuCover (proposed name) Oral Wound Dressing (K253816) | MoleculeX Co., Ltd. | 2026-05-21 |
| Dental Cone; Dental Sponge (K253758) | Medizin Produkte Neustadt GmbH (Mpn) | 2025-12-18 |
| Silatrix Oral Gel (K252425) | Sa3, LLC | 2025-10-23 |
| Elemental Granulate (K241283) | Zinkh NV | 2025-01-03 |
| HealiAid Dental Collagen Wound Dressing (K230529) | Maxigen Biotech, Inc. | 2023-11-22 |
| PerioStom Dental Dressing (K221428) | Forward Science, LLC | 2022-12-22 |
| Ora-Aid (K211851) | Tbm Corporation | 2022-01-11 |
| PuraStat-OM (K210211) | 3-D Matrix, Inc. | 2021-10-08 |
| MucoLock Oral Gel (K203091) | Pcca, Inc. | 2021-02-12 |
| Silatrix Oral Gel (K202000) | Sa3, LLC | 2020-11-20 |
Recalls involving this device
No recalls on record reference this clearance.