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Found 10 results
510(k) Data Aggregation
K Number
K121880Device Name
DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2012-09-25
(89 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DMRC Nanoflow and DMRC Nanocomposite are designed for use in all classes of cavities. DMRC Nanoflow is a low viscosity composite and DMRC Nanocomposite is a universal viscosity composite.
Device Description
DMRC Nanoflow and DMRC Nanocomposite
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K Number
K111876Device Name
Z BOND, PRELUDE ONE
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2011-09-21
(82 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Z Bond and Prelude One are a Primer and adhesive used for:
- Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays.
- Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition.
- . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.
Device Description
Not Found
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K Number
K102753Device Name
TURBO TEMP 3
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2011-02-04
(134 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.
Device Description
Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.
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K Number
K092912Device Name
STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2009-12-16
(85 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StarFill 2B HV and LV are dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate.
Device Description
dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives
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K Number
K092319Device Name
STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2009-09-16
(43 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an additional-cure viny| polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.
Device Description
Not Found
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K Number
K090106Device Name
PRELUDE ONE
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2009-03-31
(89 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.
Device Description
Prelude One is a dental bonding agent used to restore all classes of cavities
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K Number
K040952Device Name
PRELUDE
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2004-06-29
(78 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.
Device Description
Prelude is a dental bonding agent used to restore all classes of cavities.
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K Number
K033215Device Name
PREPAIR
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2004-01-09
(98 days)
Product Code
KOJ
Regulation Number
872.6080Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
Device Description
The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.
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K Number
K020760Device Name
STARFLOW HV
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2002-05-03
(57 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.
Device Description
Starflow HV is a light-cured, hybrid dental retorative which incorporates BIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) to yield a flowable dental restorative.
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K Number
K012354Device Name
SNOWPOST, SNOWLIGHT
Manufacturer
DANVILLE MATERIALS, INC.
Date Cleared
2001-10-10
(77 days)
Product Code
ELR
Regulation Number
872.3810Why did this record match?
Applicant Name (Manufacturer) :
DANVILLE MATERIALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Snowpost & Snowlight posts are indicated for use wherever root canal posts are required Showpost & Showingin posts are mellor and/or where known metal allergies are of concern.
Device Description
Not Found
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