NaturaJel Oral Wound Care Kit— 510(k) K260120
Substantially EquivalentHCS Innovation, LLC
FDA 510(k) clearance K260120 for NaturaJel Oral Wound Care Kit, Substantially Equivalent on 2026-08-05. Applicant: HCS Innovation, LLC. Device class: Unclassified.
Summary
HCS Innovation's NaturaJel Oral Wound Care Kit is filed under product code OLR, oral wound dressings. The record doesn't list the kit's contents.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Dental review panel handled it as a Traditional 510(k).
HCS Innovation filed from Union Grove, Alabama. The decision came 202 calendar days after receipt (January 15 to August 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- HCS Innovation, LLC
- Product code
- Product code OLR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union Grove, AL, US
Recent devices under product code OLR
view allAdverse events under product code OLR
product code OLR- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.