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510(k) Data Aggregation

    K Number
    K240660
    Device Name
    Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2024-09-17

    (193 days)

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

    Kulzer, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Signum metal bond: - Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with micromechanical retention. - Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates). - Bonding agent for extraoral repair of metal supported composite veneers. Signum universal bond: Metal - Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with macromechanical retentions. - Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates). - Bonding agent for the extraoral repair of metal-supported composite veneers. Zirconium dioxide - Bonding agent between frameworks, implant abutments and single crowns made of ZrO3 and lightcuring veneering materials. - Bonding agent for the extraoral repair of composite veneers on ZrO2 frameworks. High performance polymers (PEEK) - Bonding agent between frameworks, implant abutments and individual crowns made of high performance polymers and light-curing veneering materials. - Bonding agent between partial framework surfaces made of high-performance polymers and lightcuring veneering materials or denture base materials (hot or auto-polymerizate). - Bonding agent for the extraoral repair of composite veneers on PEEK frameworks. Signum liquid: For light-curing veneering materials from Kulzer: - Restoring the dispersion layer of light curing veneering materials. Signum composite / Signum composite flow / Signum matrix: Suitable for veneering the following dental framework materials: Metal alloys (precious metal, non-precious or titanium), zirconia, high-performance polymers (PEEK) Suitable for partial alteration of the colour and shape of the following dental materials: • PMMA • Photopolymers Suitable for the following prosthetic restorations: • full and partial veneers for permanent framework-supported crowns and bridges • veneering removable combination prosthetics (telescopic and tapered crowns and at-tachment prosthetics) • veneering of superstructures/tertiary structures on implants • metal-free front tooth and posterior tooth temporary restorations • alteration of the colour and shape of Kulzer acrylic denture teeth • alteration of the colour and shape of acrylic-based frameworks (PMMA). • alteration of the colour and shape of Kulzer photopolymers that are approved for char-acterisation with Signum components (according to the photopolymer instructions for use) Signum cre-active: Individual characterization (e.g., of enamel cracks, white spots, imitation fillings, enamel wedges, intermediate colour layers, abrasion surfaces, fissures) of • light-curing Kulzer veneering materials, • Kulzer denture acrylic teeth and PMMA, • (meth-)acrylate-based 3D printing photopolymers in accordance with the photopolymer instructions for use
    Device Description
    Signum Bondings (Signum metal bond) are intended for dental works in the laboratory as an adhesion promoter between a given framework made of zirconium dioxide, dental alloys, high performance composites, PMMA, and a second material (e.g. composites or acrylics). These primers are only applied in the laboratory. After restorative work, Signum bondings are encapsulated between framework and the restoration/veneering material and a direct contact to the patient is very unlikely. Signum metal bond is a liquid stored in a 5 mL bottle with dropper and red cap. Signum universal bond is a liquid stored in a 5 mL bottle with dropper and blue cap. Signum liquid is indicated for light-curing materials from Kulzer to simplify modeling procedures and restore the dispersion layer of light-curing veneering materials. Signum liquid is foreseen for dental works in the laboratory, where an adhesion promoter between a given composite layer and a second acrylate based material, including procedures is necessary. After completion of the restorative work, Signum liquid is encapsulated between both layers and a direct contact to the patient is very unlikely. Signum liquid is a liquid stored a 5 mL bottle with a spout and red cap. Signum composite, Signum composite flow, and Signum matrix are veneering composites for crowns and bridges. The veneering composites are processed by dental technicians for dental restoration by veneering framework supported restorations (for example metal or zirconia frameworks). After light activated polymerization is inserted into the oral cavity of a specific patient as a custom made device, adapted and connected to the remaining residual teeth or functionally adapted. The veneering composites are pastes stored in a syringe featuring a plunger and a closing cap. Signum cre-active are a light-curing color fluids for crown and bridge techniques and prosthetics. Signum cre-active is used in the dental laboratory to create customized characterizations of dental prosthetic works, that are then inserted into the oral cavity of a specific patient as individualized medical devices, adapted, and connected to the remaining residual teeth or functionally adapted to the edentulous alved Signum cre-activelayers must be covered with veneering material, there is no direct patient contact. Signum cre-active are liquids stored in a syringe featuring a plunger and a closing cap.
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    K Number
    K233868
    Device Name
    dima Print Teeth & Temp
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2024-05-23

    (169 days)

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

    Kulzer, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications - Long-term temporary restorations (up to 6 months), - Teeth for removable dentures
    Device Description
    dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.
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    K Number
    K230644
    Device Name
    Signum opaque F
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2023-09-07

    (183 days)

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

    Kulzer, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.
    Device Description
    Signum opaque F is a light-curing, one component opaquer used for extraoral color-masking of framework structures for crowns, bridges, and/or partial dentures. The veneering composites are processed by dental restoration by veneering framework-supported restorations, such as metal or zirconia frameworks. Signum opaque F is a paste stored in a syringe featuring a plunger and a closing cap. The product is dispensed and is then applied with a disposable brush until the scaffolding frame is completely covered. After polymerization, the crown or bridge is inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted.
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    K Number
    K220605
    Device Name
    Venus Bulk Flow ONE
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2022-04-21

    (50 days)

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

    Kulzer, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
    Device Description
    Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.
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    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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