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510(k) Data Aggregation

    K Number
    K191385
    Device Name
    BRILLIANT COMPONEER
    Manufacturer
    Coltene/Whaledent AG
    Date Cleared
    2019-10-29

    (159 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clinical indications - Restoration of caries defects - Reconstruction of lost tooth substance due to attrition, abrasion, erosion - Restoration of tooth fractures - Correction of anatomical malformation Cosmetic indications - Optimization of old composite restorations - Extending incisors - Correction of malpositioned teeth - Cosmetic corrections for tooth discoloration or incorrect shading - Closure of diastema
    Device Description
    The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration.
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    K Number
    K190597
    Device Name
    BRILLIANT EverGlow Flow
    Manufacturer
    Coltene/Whaledent AG
    Date Cleared
    2019-06-21

    (106 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for: - · Direct class V fillings (cervical caries, root erosion, wedge-shaped defects) - · Fillings in the anterior tooth region (Class III and IV) - · Small fillings of all cavity classes (not occlusion-bearing) - · Blocking out of undercuts - · Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given - · Repairs of direct and indirect composite restorations - · Preventive resin restorations - · Cavity lining BRILLIANT EverGlow Flow opaque shade is also suitable for: - · Aesthetic corrections (e.g. deviations in chroma) - · Masking of dark areas
    Device Description
    BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in several shades that allows for high aesthetic restorations with a clear spectrum of shades. It is applied in the increment technique and available in 7 universal, 2 translucent and 3 opaque shades. BRILLIANT EverGlow Flow is chemically characterized by its composition, which can be categorized in three groups based on their chemical and functional similarity: resin components (matrix monomers based on methacrylates), fillers, and additives. The largest part of BRILLIANT EverGlow Flow's composition is represented by fillers (>58% w/w), followed by resin components (<40% w/w), and additives (<2% w/w). BRILLIANT EverGlow Flow is, after curing, a crosslinked methacrylate-based composite material with a three-dimensional polymer network, containing embedded filler particles and incorporated additives. BRILLIANT EverGlow Flow has long term contact (>30 days) with tissue/bone/dentin. BRILLIANT EverGlow Flow is the supplemental flowable, radiopaque submicron hybrid material version of the universal composite BRILLIANT EverGlow. BRILLIANT EverGlow Flow is, due to its lower viscosity, considered an enhancement of BRILLIANT EverGlow for applications with non-easily accessible areas in the oral cavity (e.g. blocking out of undercuts) and/or extended fissure-sealing. BRILLIANT EverGlow Flow combines a low viscous consistency with high stability and thixotropy, allowing a controlled and comfortable application. BRILLIANT EverGlow Flow is available in different shades and gradations of translucency. BRILLIANT EverGlow Flow is delivered with two application needle sizes (standard size [Ø 0.8mm] and fine size [Ø 0.4mm]). The fine size needle is to improve the accessory range and to allow an application with higher precision.
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    K Number
    K181500
    Device Name
    BRILLIANT Crios
    Manufacturer
    Coltene/Whaledent AG
    Date Cleared
    2018-08-15

    (69 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRILLIANT Crios is indicated for: - Crowns, inlays, onlays and veneers - Implant-supported crowns.
    Device Description
    BRILLIANT Crios is a radiopaque composite material composed of crosslinked methacrylate based polymerized monomers and dental glass fillers. The subject device is made available in block forms of different sizes, shades and translucencies for the fabrication of permanent tooth restorations such as inlays, onlays, crowns and veneers using CAD/CAM milling equipment.
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    K Number
    K160800
    Device Name
    DuoCem
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2016-11-16

    (238 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DuoCem is indicated for: - permanent cementing of crowns, inlays, onlays (ceramic, metal, composite) - permanent cementing of root posts of all types
    Device Description
    Not Found
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    K Number
    K152927
    Device Name
    BRILLIANT EVERGLOW
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2016-04-28

    (206 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for: - Direct filling of class I, II, III, IV and V cavities - Cementation and repair of composite and ceramic restorations (e.g. COMPONEER) BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for: - Shape and color corrections to enhance the individual esthetics - Reconstruction of incisal edges - Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)
    Device Description
    Not Found
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    K Number
    K152243
    Device Name
    One Coat 7 Universal
    Manufacturer
    Coltene/Whaledent AG
    Date Cleared
    2015-12-09

    (121 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Coat 7 Universal is indicated for: - bonding in adhesive restoration techniques - adhesive attachment of composite materials and compomers on enamel and dentin - adhesive attachment of ceramic and composite restorations on enamel and dentine - composite material on ceramic, composite material, metal and amalgam - dentine sealing
    Device Description
    Not Found
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    K Number
    K150218
    Device Name
    Fill-Up!
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2015-06-23

    (144 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining - first layer for class I and II cavities - core build-ups
    Device Description
    Not Found
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    K Number
    K121621
    Device Name
    SOLOCEM
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2013-01-08

    (221 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SoloCem is indicated for - permanent cementation of root posts of all types - permanent cementation of crowns, bridges, inlays, onlays - permanent cementation of implant abutments
    Device Description
    Not Found
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    K Number
    K112168
    Device Name
    COMPONEER
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2011-11-21

    (116 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - -restoration therapy for caries - -optimisation of old restorations - -tooth fractures - -extending incisors - -malpositioned teeth - -tooth discoloration, incorrect shading - -anatomical malformation - -diasteme - -attrition, abrasion, erosion - -cosmetic correction
    Device Description
    COMPONEER are polymerised, radio-opaque composite shells
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    K Number
    K083304
    Device Name
    TEMPOSIL 2
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2009-02-06

    (88 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TempoSIL 2 is indicated for - temporary cementation of provisional restorations - temporary cementation of provisional restorations on implant abutments - temporary cementation of final crown and bridges - temporary cementation of final crowns and bridges on implant abutments
    Device Description
    Not Found
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