Cleared Traditional

K260126 - Curajel™ Oral Gel

K260126 · USpharma, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
151d
Days
-
Risk

K260126 is an FDA 510(k) clearance for the Curajel™ Oral Gel. Classified as Oral Wound Dressing (product code OLR).

Submitted by USpharma, Ltd. (Miami Lakes, US). The FDA issued a Cleared decision on June 15, 2026 after a review of 151 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 USpharma, Ltd. devices

FDA 510(k) Submission Details - K260126

510(k) Number K260126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2026
Decision Date June 15, 2026
Days to Decision 151 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
23d slower than avg
Panel avg: 128d · This submission: 151d
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 Consultant

Eliquent Life Sciences, Inc.
Samantha Eakes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLR Oral Wound Dressing

All 39
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K260126.
NaturaJel™ Oral Wound Care Kit
K260120 · HCS Innovation, LLC · Aug 2026
Emanate Tray
K251908 · Emanate Biomedical · Jul 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