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510(k) Data Aggregation

    K Number
    K141994
    Device Name
    BULK FILL FLOWABLE COMPOSITE
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2014-11-14

    (115 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why 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
    K130601
    Device Name
    BIOROOT RCS
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2013-10-17

    (224 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why 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
    K120237
    Device Name
    BPA-FREE MICROHYBID COMPOSITE
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2012-12-11

    (320 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why 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
    K120283
    Device Name
    DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2012-07-31

    (182 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why 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
    K120619
    Device Name
    ORTHODONTIC FLOWABLE BRACKET ADHESIVE
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2012-05-21

    (82 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why 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
    K110484
    Device Name
    SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2011-05-17

    (88 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why 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
    K092501
    Device 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
    872.3690
    Why 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
    K072150
    Device Name
    DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2007-09-13

    (41 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why 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
    K040343
    Device Name
    TEMP F
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2004-08-03

    (173 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why 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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