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510(k) Data Aggregation
K Number
K070842Device Name
ULCELOOCIN ORAL ULCER PATCH
Manufacturer
SUNSHINE INTERNATIONAL GROUP, INC.
Date Cleared
2007-06-07
(72 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SUNSHINE INTERNATIONAL GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ulceloocin™ Oral Ulcer Patch is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
Device Description
Ulceloocin™ Oral Ulcer Patch is a vacuum-dried gel that contains hydrogel with calcium and phosphorus. It does not contain any biological additives or drugs. It is a round, white to off-white thin patch. Ulcelocin™ Oral Ulcer patch is packaged in blister cards of two patches per card, three blister cards per carton, for a total of 6 patches per carton. Each patch is approximately 1 cm in diameter and 0.3 mm thick.
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