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510(k) Data Aggregation

    K Number
    K191385
    Device Name
    BRILLIANT COMPONEER
    Date Cleared
    2019-10-29

    (159 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2019-06-21

    (106 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2018-08-15

    (69 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2016-11-16

    (238 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2016-04-28

    (206 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2015-12-09

    (121 days)

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

    Coltene/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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!
    Date Cleared
    2015-06-23

    (144 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    K130137
    Device Name
    BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
    Manufacturer
    Date Cleared
    2013-08-23

    (217 days)

    Product Code
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry. The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation and polishing of teeth by the projection of water, air and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces or smooth surfaces of teeth. The BioSonic Suvi Air Polisher is also indicated for the nonsurgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
    Device Description
    The BioSonic Suvi Piezoelectric Scaler and Air Polisher (BioSonic Suvi) is a combination scaler and polisher device for use in dental care. It combines the functions of an ultrasonic scaler and dental air polisher into a single device. The scaler is used for removal of tartar or calculus on teeth and other dental work where ultrasonic vibration is beneficial. The polisher unit is used for removal of plaque, cleaning discolored teeth and other dental work where air polishing is beneficial. The BioSonic Suyi will be offered in (4) four different models. These are the BioSonic Suvi Premier, BioSonic Suvi Premier Plus, BioSonic Suvi Elite and the BioSonic Suvi Elite Plus. The Premier and Premier Plus are scalers only. The Elite and Elite Plus are combination scaler and polisher units The Premier and Plus versions differ in whether they include a standard tap water supply attachment or an optional medicament dispenser system. The standard tap water versions connect directly to a tap water supply using a hose connection. The medicament dispenser system provides either medicine or clean water using a medicament bottle which connects to the side of the unit. The medicament versions utilize an internal air compressor to pressurize the medicament. During use, compressed air forces fluids from the bottle, through the hose, to the hand piece and the tip/nozzle. Thus medication can be provided if desired.
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    K Number
    K121621
    Device Name
    SOLOCEM
    Date Cleared
    2013-01-08

    (221 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2011-11-21

    (116 days)

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

    COLTENE/WHALEDENT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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