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510(k) Data Aggregation

    K Number
    K050984
    Device Name
    BIOPLANT
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2005-08-11

    (114 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bioplant is a synthetically derived, spherical material which is intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the below indications. 1) To maintain and restore the bony alveolar ridge after extraction of tooth-roots, i.e., Ridge preservation/Socket grafting; 2) To restore infra-bony defects caused by destructive periodontal disease, i.e., 2-3 wall defects/Class I, II and III furcations; 3) To augment bony defects, i.e., apicocctomies, cystic formation or tumor removal; 4) Ridge augmentation to restore the height and/or width of severely atrophicd alveolar ridges; 5) Augmentations in the maxillary sinus; 6) Trone voids associated with implant placement.
    Device Description
    Bioplant is a synthetic polymer bone void filling material which, due to its porosily characteristics, is capable of supporting ingrowth of bony tissue. This non-resorbable and radio-opaque material is used to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The material consists of poly methylmethacrylate (PMMA) beads coated with poly hydroxyethyl methacrylate (PHEMA) to increase hydrophlicity of the porous structure, a thin layer of barium sulfate for radio-opacity, and calcium hydroxide for hydrophilicity and to promote bone growth around the PMMA beads. The average particle size of the beads is 750 microns. The product is sterliked using gamma radiation.
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    K Number
    K031444
    Device Name
    OPTIBOND FL
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2003-07-02

    (56 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.
    Device Description
    The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.
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    K Number
    K030646
    Device Name
    BELLEGLASS POINT 4
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2003-05-06

    (67 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    belleGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.
    Device Description
    belieGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.
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    K Number
    K020303
    Device Name
    XR PRIMER 2
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2002-04-19

    (80 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
    Device Description
    XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.
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    K Number
    K020178
    Device Name
    BELLEGLASS HP MODELING GEL
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2002-03-15

    (56 days)

    Product Code
    EBG, EBF
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and sculpting layers of composites and it is to be used between layers of cured composite.
    Device Description
    belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.
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    K Number
    K014027
    Device Name
    OPTIBOND SOLO PLUS 4
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2002-02-22

    (78 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).
    Device Description
    OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.
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    K Number
    K020092
    Device Name
    TEMPHASE
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2002-02-22

    (43 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temphase is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
    Device Description
    Temphase temporary crown and bridge material is a two component, catalyst and base, material dispensed and mixed by a cartridge/static mixing tip combination. Temphase is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Temphase contains methacrylate components and is radiopaque for easy radiographic identification.
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    K Number
    K013375
    Device Name
    BELLEGLASS HP OPAQUE 2
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2001-10-29

    (18 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BelleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.
    Device Description
    belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations. belleGlass HP Opaque 2 is also used with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.
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    K Number
    K013325
    Device Name
    POINT 4 FLOWABLE 2
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2001-10-23

    (18 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
    Device Description
    Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
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    K Number
    K011908
    Device Name
    OPTIBOND SOLO PLUS 3
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2001-09-06

    (79 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR DENTAL MATERIALS CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, and post cementation.
    Device Description
    The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.
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