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510(k) Data Aggregation
K Number
K082553Device Name
REXASTOM ORAL EASE
Manufacturer
Date Cleared
2008-11-21
(79 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
REXADERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RexaStom™ Oral Ease has a mechanical barrier action indicated for the temporary relief of pain by adhering to the mucosal surface of the mouth, covering and soothing oral lesions of various etiologies. The lesions include oral mucositis resulting from chemo- or radiation therapy, stomatitis, irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, aphthous ulcers, or other diseases or conditions of the oral mucous surfaces.
Device Description
RexaStom Oral Ease is a dry, wafer or matrix type material, similar to coarse blotting paper. For mucositis, it is supplied in a 2.5-cm curcular format, packaged in a vacuumsealed, foil packet. Its ingredients are either food grade or generally regarded as safe and therefore the wafer material is safe when swallowed. RexaStom is designed to be physiologically compatible with both intact and compromised tissue in the mouth, and provides temporary management of pain associated with various types of injuries to the mouth.
RexaStom's primary mode of action for pain relief is that it adheres to the wound surface, conforms to the contour of the wound, and protects the wound from contamination and irritation by forming a temporary protective barrier that is similar to the natural mucosa.
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