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510(k) Data Aggregation
K Number
K083398Device Name
CERCOM CEMENT
Manufacturer
Date Cleared
2009-01-26
(70 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DENALI R&D CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
Device Description
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
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K Number
K083473Device Name
CLEAR BRAVO
Manufacturer
Date Cleared
2009-01-22
(59 days)
Product Code
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
DENALI R&D CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is available in either fluoride and non-fluoride releasing formulas
Device Description
Clear Bravo is a clear, light-cured pit and fissure sealant and sealer for application to the surfaces of teeth, sealing of composite margins and temporary restorations Clear Bravo is crystal clear which allows observation of conditions which may occur beneath the sealant This would include possible leakage, staming and also allows the use of canes detecting devices Clear Bravo is available in either fluoride and non-fluoride releasing formulas
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