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Found 3 results
510(k) Data Aggregation
K Number
K210115Device Name
FiteBac CC OrthoSeal
Manufacturer
Largent Health, LLC
Date Cleared
2021-07-29
(191 days)
Product Code
DYH, FIT
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
Largent Health, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
Device Description
The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
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K Number
K200614Device Name
FiteBac Antimicrobial Cavity Cleanser
Manufacturer
Largent Health, LLC
Date Cleared
2020-06-25
(108 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Largent Health, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Device Description
The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface.
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K Number
K190271Device Name
FiteBac Cavity Cleanser
Manufacturer
Largent Health, LLC
Date Cleared
2020-01-23
(349 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Largent Health, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Device Description
The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.
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