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510(k) Data Aggregation
K Number
K081372Device Name
GELX ORAL GEL
Manufacturer
BMG PHARMA LLC.
Date Cleared
2009-02-04
(264 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BMG PHARMA LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BMG Pharma's GelX® ORAL GEL has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.
Device Description
BMG Pharma's GelX® ORAL GEL is a viscous gel formulation, which is presented in both 300 ml and 450 ml bottles. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
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