Curajel Oral Gel— 510(k) K260126

Name: FDA 510(k) clearance K260126
Creator: U.S. Food and Drug Administration
Published: 2026-06-15

Substantially Equivalent

USpharma, Ltd.

FDA 510(k) clearance K260126 for Curajel Oral Gel, Substantially Equivalent on 2026-06-15. Applicant: USpharma, Ltd.. Device class: Unclassified.

Summary

USpharma's Curajel Oral Gel is filed under OLR, oral wound dressings. The record doesn't give the gel's ingredients.

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).

USpharma filed from Miami Lakes, Florida. The decision came 151 calendar days after FDA received it (January 15 to June 15, 2026).

Clearance details

Applicant: USpharma, Ltd.
Product code: Product code OLR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-01-15
Decision date: 2026-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLR

view all

K260120 — NaturaJel Oral Wound Care Kit2026-08-05
K251908 — Emanate Tray2026-07-29
K253816 — MuCover (proposed name) Oral Wound Dressing2026-05-21
K253758 — Dental Cone; Dental Sponge2025-12-18
K252425 — Silatrix Oral Gel2025-10-23

Adverse events under product code OLR

product code OLR

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.