Cleared Traditional

K260120 - NaturaJel™ Oral Wound Care Kit

K260120 · HCS Innovation, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
202d
Days
-
Risk

K260120 is an FDA 510(k) clearance for the NaturaJel™ Oral Wound Care Kit. Classified as Oral Wound Dressing (product code OLR).

Submitted by HCS Innovation, LLC (Union Grove, US). The FDA issued a Cleared decision on August 5, 2026 after a review of 202 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all HCS Innovation, LLC devices

FDA 510(k) Submission Details - K260120

510(k) Number K260120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2026
Decision Date August 05, 2026
Days to Decision 202 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 127d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 29
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K260120.
Emanate Tray
K251908 · Emanate Biomedical · Jul 2026
Curajel™ Oral Gel
K260126 · USpharma, Ltd. · Jun 2026
MuCover (proposed name) Oral Wound Dressing
K253816 · MoleculeX Co., Ltd. · May 2026
Dental Cone
K253758 · Medizin Produkte Neustadt GmbH (Mpn) · Dec 2025
Silatrix Oral Gel
K252425 · Sa3, LLC · Oct 2025
Elemental Granulate
K241283 · Zinkh NV · Jan 2025