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Found 16 results
510(k) Data Aggregation
K Number
K240660Device 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
872.3690Why 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
K233868Device Name
dima Print Teeth & Temp
Manufacturer
Kulzer, LLC
Date Cleared
2024-05-23
(169 days)
Product Code
EBG, POW, PZY
Regulation Number
872.3770Why 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
K230644Device Name
Signum opaque F
Manufacturer
Kulzer, LLC
Date Cleared
2023-09-07
(183 days)
Product Code
EBF
Regulation Number
872.3690Why 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
K220605Device Name
Venus Bulk Flow ONE
Manufacturer
Kulzer, LLC
Date Cleared
2022-04-21
(50 days)
Product Code
EBF
Regulation Number
872.3690Why 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
K160049Device Name
Charisma
Manufacturer
Heraeus Kulzer, LLC (Mitsui Chemicals Group)
Date Cleared
2016-11-15
(309 days)
Product Code
EBF
Regulation Number
872.3690Why 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
K130647Device 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
872.3660Why 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
K123278Device 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
872.3200Why 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
K120914Device Name
FLEXITIME FAST & SCAN LIGHT FLOW
Manufacturer
HERAEUS KULZER, LLC
Date Cleared
2012-07-25
(120 days)
Product Code
ELW
Regulation Number
872.3660Why 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
K113574Device Name
FLEXITIME MONOPHASE PRO SCAN
Manufacturer
HERAEUS KULZER, LLC
Date Cleared
2012-07-13
(224 days)
Product Code
ELW
Regulation Number
872.3660Why 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
K112501Device Name
VENUS PEARL PLT REFILL A1
Manufacturer
HERAEUS KULZER, LLC
Date Cleared
2011-12-14
(106 days)
Product Code
EBF
Regulation Number
872.3690Why 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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