OLR

Oral Wound Dressing

Product code
OLR
Device name
Oral Wound Dressing
Device class
Class U
Medical specialty
Unknown
Marketing pathway
510(K)
510(k) clearances (last 3 years)
43

FDA classification definition

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-08-05.

NumberDecision dateApplicantDevice nameSummary
K2601202026-08-05HCS Innovation, LLCNaturaJel™ Oral Wound Care KitPDF
K2519082026-07-29Emanate BiomedicalEmanate TrayPDF
K2601262026-06-15USpharma, Ltd.Curajel™ Oral GelPDF
K2538162026-05-21MoleculeX Co., Ltd.MuCover (proposed name) Oral Wound DressingPDF
K2537582025-12-18Medizin Produkte Neustadt GmbH (Mpn)Dental Cone; Dental SpongePDF
K2524252025-10-23Sa3, LLCSilatrix Oral GelPDF
K2412832025-01-03Zinkh NVElemental GranulatePDF
K2305292023-11-22Maxigen Biotech, Inc.HealiAid Dental Collagen Wound DressingPDF

8 summaries are archived here for direct download.

Official FDA classification page: OLR
Classification and pathway per current FDA publications. Data from openFDA (CC0).