Device typeGeneral oral wound dressing, non-animal-derived: A compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by trauma, surgery, radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.
FDA categoryDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, Oral Wound Dressing
Device ID00370275713050
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information