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Found 9 results
510(k) Data Aggregation
K Number
K141994Device Name
BULK FILL FLOWABLE COMPOSITE
Manufacturer
NOVOCOL, INC.
Date Cleared
2014-11-14
(115 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Base under Class I and II direct restorations
- Liner under direct restorative materials
- Class III and V restorations
- Undercut Blockout
- Minimally invasive cavities (including small non stress-bearing occlusal restorations)
- Tunnel preparations
- Repair of small enamel defects
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
Device Description
The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties. The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are: A1, A2, A3, A3.5.
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K Number
K130601Device Name
BIOROOT RCS
Manufacturer
NOVOCOL, INC.
Date Cleared
2013-10-17
(224 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BioRoot™ RCS is intended to be used for permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioRoot™ RCS is suitable for use in single cone technique or cold lateral condensation and is reserved for professional dental use only.
Device Description
Not Found
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K Number
K120237Device Name
BPA-FREE MICROHYBID COMPOSITE
Manufacturer
NOVOCOL, INC.
Date Cleared
2012-12-11
(320 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microhybrid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class i, II, III, IV, and V, and diastema closure.
Device Description
Microhybrid Composite
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K Number
K120283Device Name
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
Manufacturer
NOVOCOL, INC.
Date Cleared
2012-07-31
(182 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.
"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.
Device Description
Not Found
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K Number
K120619Device Name
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
Manufacturer
NOVOCOL, INC.
Date Cleared
2012-05-21
(82 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.
Device Description
Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.
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K Number
K110484Device Name
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
Manufacturer
NOVOCOL, INC.
Date Cleared
2011-05-17
(88 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Self Cure Temporary Crown and Bridge Material" is indicated for the fabrication of temporary crown, partial crown, inlay, onlay and/or bridges.
Device Description
Not Found
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K Number
K092501Device Name
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
Manufacturer
NOVOCOL, INC.
Date Cleared
2009-11-12
(90 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. It may also be used for dental core build-ups
Device Description
Light-Activated Low-Stress Thiol-Ene Composite Restorative Material
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K Number
K072150Device Name
DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
Manufacturer
NOVOCOL, INC.
Date Cleared
2007-09-13
(41 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"Dimer Acid Derived Nanohybrid Composite" is a light cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides simple esthetics since it is formulated in shades matching the VITA Lumin Shade guide. This low shrinkage nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V.
Device Description
Dimer acid derived nanohybrid composite is for use in all dental cavity classes. The composite is a single light cured paste with a different monomer system chemistry than other filling composites that are currently available. The new resin system produces exceptionally high conversion values with a very low shrinkage.
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K Number
K040343Device Name
TEMP F
Manufacturer
NOVOCOL, INC.
Date Cleared
2004-08-03
(173 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
NOVOCOL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temp F is indicated for the following applications: Temp F is a paste for consumer application to temporarily repair teeth with cavities and lost fillings and inlays.
Device Description
Temp F is a paste
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