510(k) K260120
K260120 is an FDA 510(k) premarket notification submitted by HCS Innovation, LLC for the device "NaturaJel Oral Wound Care Kit". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code OLR (Oral Wound Dressing), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2026
- Date Received
- January 15, 2026
- 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.