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510(k) Data Aggregation
K Number
K123904Device Name
PROTHELIAL
Manufacturer
MUELLER MEDICAL INTERNATIONAL LLC
Date Cleared
2013-08-07
(231 days)
Product Code
FRO, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MUELLER MEDICAL INTERNATIONAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProThelial™ & Orafate Sucralfate Malate Paste forms a protective layer over the oral mucosa by adhering to the mucosal surface which allows it to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
Device Description
ProThelial™ & Orafate Sucralfate Paste is an amorphous hydrogel paste formed by the controlled reaction of sucralfate with a limited quantity of malic acid and calcium carbonate solution. The amorphous hydrogel paste formed by this reaction binds reversibly to wounds and is intended to form a protective film that covers wounds, protects against further irritation and relieves pain. ProThelial™ & Orafate Sucralfate Paste may be administered directly to an accessible oral wound to provide an adherent physical covering of the wound bed. Although prepared by reaction of sucraffate with an acid, the polymerized sucralfate self-buffers to a pH 5.0 - 7.0.
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