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510(k) Data Aggregation

    K Number
    K160049
    Device Name
    Charisma
    Manufacturer
    Heraeus Kulzer, LLC (Mitsui Chemicals Group)
    Date Cleared
    2016-11-15

    (309 days)

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

    Heraeus Kulzer, LLC (Mitsui Chemicals Group)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct restoration of Class I-V cavities (according to G.V. Black) Direct composite veneers Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) Splinting of teeth loosened by trauma or periodontal disease Restoration of primary teeth Repairs of porcelain, composite (in combination with an adequate repair-system)
    Device Description
    Not Found
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    K Number
    K130647
    Device Name
    XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2013-05-17

    (67 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.
    Device Description
    Xantasil is an addition-curing polyvinyl-siloxane impression material. Xantasil is delivered in 50 ml and 380 ml cartridges. Xantasil is an optimized A-silicone impression material with medium consistency meant as a replacement for alginates. The mouth removal time for the product is 1.5 minutes Xantasil is for use in the Dynamix automatic dispensing and mixing system and the 1:1 Cartridge dispenser.
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    K Number
    K123278
    Device Name
    IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2012-12-07

    (46 days)

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

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iBond Self Etch is used for bonding of direct light-cured composite restorations (including Polyglas and copomers), bonding of indirect restorations in combination with a light-curing luting cement; porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns) and sealing hypersensitive areas of teeth.
    Device Description
    iBond Self Etch(new formulation is an acetone/water-based formulation of light activated methylacrylate resins.
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    K Number
    K120914
    Device Name
    FLEXITIME FAST & SCAN LIGHT FLOW
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2012-07-25

    (120 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, endentulous and partial impression. The Flexitime Fast & Scan range of products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 shape D700 laser scanners.
    Device Description
    Flexitime Fast & Scan Impression Materials are addition-cross-linking polyvinyl siloxane materials. The Flexitime Fast & Scan Impression Materials family consists of Light Flow, Medium Flow, Dynamix Putty, Easy Putty and Dynamix Heavy Tray. Flexitime Light Flow, Medium Flow, Heavy Tray are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty and Dynamix Heavy Tray are delivered in 380 ml Cartridges and Flexitime Fast & Scan Easy Putty is delivered in a 300 ml container. The Flexitime Fast & Scan assortment is characterized by the addition of Titanium Dioxide (in order to ensure scannability) and is technically characterized by an extra-oral working time of up to 1.5 minutes and a short time in mouth of 2.0 minutes. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners. Flexitime Fast & Scan products are part of the Flexitime System.
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    K Number
    K113574
    Device Name
    FLEXITIME MONOPHASE PRO SCAN
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2012-07-13

    (224 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.
    Device Description
    Flexitime Monophase Pro Scan is an addition-cross-linking polyvinyl siloxane impression material. Flexitime Monophase Pro Scan is delivered in 380 ml cartridges and is part of the Flexitime Dynamix System. Flexitime Monophase Pro Scan is characterized by the addition of a scannable dye (for scannability). Flexitime Monophase Pro Scan was developed to complement flexitime Monophase regarding scannability and shore hardness, thus improving the impression taking especially for dental implants. Additionally the hydrophilic characteristics for optimal impression taking in the wet surroundings combined with good mechanical properties should be ensured. The mouth retention time for the product is 2.5 minutes. Flexitime Monophase Pro Scan is for use in the Dynamix automatic dispensing and mixing svstem.
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    K Number
    K112501
    Device Name
    VENUS PEARL PLT REFILL A1
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2011-12-14

    (106 days)

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

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Direct restoration of Class I V cavities (acc. to G.V. Black) . - . Direct composite veneers - Shape corrections of teeth (i.e. diastemas, congenital defects in teeth etc.) . - Splinting of teeth loosened by trauma or periodontal disease . - . Indirect restorations (inlays, veneers) - Restoration of primary teeth . - Core build-up . - Repairs of porcelain, composite (in combination with an adequate repair . system)
    Device Description
    Venus Pearl is a, universal light-curing, radio-opaque nano-hybrid composite for antenor and posterior use. Due to the excellent material properties, a beautiful aesthetic result and a durable, high lustre polish is easily reached. Nano hybrid composite contain a blend of small particle fillers and large particle fillers that create durable and aesthetic restorations. The nano fillers panide micro that croate darable of the filler content and provide the natural aesthetic appearance. It is used as a base in Class I -- V restorations and can be placed in increments it is used as a base in Glass in Glass in othersal shades and special shades, 3 mm for the core-build-up shade and 1 mm for opaque-shades. Venus Pearl is used following the application of a dentin/enamel addlesive (e.g. Venus Fear is used lollowing the upper for use with light cured composite restorations. Venus Pearl is based on 2-Propenoic acid, (octahydro-4,7-methano-1Hindenes / Carrie bleneiminocarbonyloxy-2- , 1-ethanediy()ester (TCD-Dlindene-5-dify)blo(methyl-4,13-dioxo-3,14-dioxe-5,12-diazahexadecane-1,16diy-dimethacrylate (UDMA) (approximately 59% filler by volume, with 58% anorganic filler by volume, Banum aluminium Fluoride glass, pre-polymerized filler and highly discrete nanoparticles . The filler particle size is between 5 nm and 5 um
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    K Number
    K111832
    Device Name
    PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2011-09-29

    (93 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Paladon ultra is a heat curing high impact denture base resin designed for injection procedure and press and pack technique for: - . maxillary and mandibular prostheses - implant over-denture .
    Device Description
    Paladon ultra was developed as a heat curing high impact denture base resin similar to the substantially equivalent device Palaimpact. The product consists of powder in various shades (pink, pink veined, pink live, R50 ыланың жұмысыздың құрылы veined, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in an outer cardboard box. 12000 g are available upon request. To make a denture, powder and liquid are mixed, in a ratio of 21 g : 10 m!. The material should be polymerised by heating. The material has a shelf life of five years and fully complies with the requirements of ISO 20795-1:2008 for denture base polymers with improved impact resistance.
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    K Number
    K110037
    Device Name
    PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2011-04-29

    (113 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Universal high fracture resistant denture base material. Used with injection or pouring techniques for fixed or removable dentures. Injection procedure: - Full maxillary and mandibular prostheses - Implant over denture - Pouring procedure: - Implant over denture - Partial dentures. Multiple or single saddles - Marginal contour and reshaping - Repairs and additions - Relines - Dental splints
    Device Description
    PalaXpress ultra was developed as an auto-polymerizing denture and differs from the substantially equivalent device Palapress vario in the increased fracture resistance compared with that material. The product was developed as an autopolymerizing universal denture base material. The product consists of powder in various shades (pink veined, link live, pink opaque, R50 veined, clear, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in a outer cardboard box. 12000 g are available upon request. To make sure denture, powder and liquid are mixed, in a ratio of 30 g : 15 ml (2:1) for the injection procedure, and in a ratio of 10 g powder : 7 ml liquid for the pouring procedure, Polymerization time in the pressure vessel is 30 min, at a water temperature 55°C and a pressure of 2 bar. The material has a shelf life of 42 months and complies with the requirements of ISO 20795-1:2008 for denture base polymers.
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    K Number
    K102770
    Device Name
    FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2010-12-21

    (88 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression. The Flexitime Fast & Scan range products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape D700 laser scanners.
    Device Description
    The products are developed under the project name D 942. The Flexitime Fast & Scan Light Flow. Flexitime Fast & Scan Medium Flow and Flexitime Fast & Scan Dynamix Putty each are addition-cross-linking polyvinyl siloxane impression materials. Flexitime Fast & Scan Light Flow and Medium Flow are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty is delivered in 380 ml cartridges. They are part of the Flexitime-system. The Flexitime Fast & Scan assortment is characterized by the addition of Titanium- Dioxide (in order to ensure scannabilty) and is technically characterized by a extraoral working time of up to 1.5 min and a short time in mouth of 2.0 min. These products are highly desired for double-mix impressions (single step) and correction impressions (two step technique). The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Furthermore the materials were developed to ensure scannability with state of the art red laser light impressions scanners. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Dynamix Putty to meet the requirements of the European and US market. Flexitime Light Flow and Flexitime Medium Flow are marketed since August 2009 and Flexitime Dynamix Putty is marketed since Mav 2007.
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    K Number
    K101617
    Device Name
    FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
    Manufacturer
    HERAEUS KULZER, LLC
    Date Cleared
    2010-09-07

    (90 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexitime Xtreme 2 is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.
    Device Description
    The products are developed under the project name D 948. The Flexitime Xtreme 2 Light Flow , Medium Flow and Heavy Tray each are addition-crosslinking polyvinyl siloxane impression materials , all delivered in 50 ml cartridges, and are part of the Flexitime Xtreme -system. The Flexitime Xtreme 2 assortment is characterised by the addition of Blackbeery-aroma and is technically characterized by a short working time of appr. 1.5 min and a short time in mouth period of min. 1.5 min.. These products, which show a shorter working time and setting time, are highly desired for single step impressions especially in combination with the double arch impression technique. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Xtreme Heavy Tray to meet the requirements of the US market.
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