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Found 9 results
510(k) Data Aggregation
K Number
K153191Device Name
Calcium Bridge
Manufacturer
DENALI CORPORATION
Date Cleared
2016-02-26
(115 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins, or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.
Device Description
Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.
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K Number
K151945Device Name
Triumph Resin Dam
Manufacturer
DENALI CORPORATION
Date Cleared
2016-02-18
(219 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.
Device Description
Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.
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K Number
K152322Device Name
Resolve 2.0
Manufacturer
DENALI CORPORATION
Date Cleared
2015-12-16
(121 days)
Product Code
PME, LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
Device Description
Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
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K Number
K141503Device Name
DENALI 501CEMENT
Manufacturer
DENALI CORPORATION
Date Cleared
2014-11-10
(157 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.
Device Description
Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. Denali 501 contains polymerizable monomers that can set in either a light activated mode or set upon mixing Part A and Part B. When set the resin has a low solubility in water to act as a long term cement.
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K Number
K132393Device Name
CERCOM II CEMENT
Manufacturer
DENALI CORPORATION
Date Cleared
2014-03-14
(225 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.
Device Description
CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure.
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K Number
K073101Device Name
AURAVENEER CEMENT
Manufacturer
DENALI CORPORATION
Date Cleared
2008-01-17
(93 days)
Product Code
EMA, 872
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.
Device Description
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations. This veneer cement is made from a complimentary hydrophilic resin and filler system, which creates compatibility between the tooth surface and restorative materials. AURAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding agents when bonding to dentin is not required. Equally, the surface of the restoration should also be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents are not required for the use of this product.
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K Number
K071158Device Name
AURALAY PIT & FISSURE SEALANT
Manufacturer
DENALI CORPORATION
Date Cleared
2007-06-05
(41 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.
Device Description
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.
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K Number
K070702Device Name
FUSION RESIN CEMENT AND CORE KIT
Manufacturer
DENALI CORPORATION
Date Cleared
2007-05-10
(58 days)
Product Code
EBF, 872
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.
Device Description
Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination
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K Number
K070693Device Name
AURAVUE PIT & FISSURE SEALANT
Manufacturer
DENALI CORPORATION
Date Cleared
2007-05-09
(57 days)
Product Code
EBF, EBC
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DENALI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel marqins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
Device Description
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
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