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510(k) Data Aggregation
K Number
K993556Device Name
LIQUIBAND DENTAL
Manufacturer
Date Cleared
2000-01-03
(75 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MEDLOGIC GLOBAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LiquiBand® Dental n-butyl cyanoacrylate is intended for use as an adhesive when bonding of caps and crowns to teeth is desired.
Device Description
The LiquiBand® Dental adhesive formula consists of n-butyl cyanoacrylate monomer containing small amounts of hydroquinone (a free radical inhibitor) and sulfur dioxide (an anionic inhibitor).
LiquiBand® Dental, n-butyl cyanoacrylate adhesive, is a clear, colorless, free-flowing liquid packaged in a single use, 0.5 gram high density polyethylene ampoule with an attachable polypropylene applicator tip. It is applied as a liquid monomer to the bonding surface of the cap/crown to be cemented to a tooth. Upon seating the cap/crown and contact with weak bases LiguiBand® Dental polymerizes as to form a strong adhesive bond between the cap/crown and tooth.
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K Number
K972081Device Name
SUPERSKIN
Manufacturer
Date Cleared
1997-12-17
(197 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MEDLOGIC GLOBAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices.
SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear.
Do not apply over broken skin.
Device Description
SuperSkin® is a topically-applied skin protectant for use on unbroken skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
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