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510(k) Data Aggregation

    K Number
    K240735
    Device Name
    visio.lign color, visio.lign shield
    Manufacturer
    Bredent GmbH & Co. KG
    Date Cleared
    2024-12-12

    (269 days)

    Product Code
    EBD, EBI, ELM
    Regulation Number
    872.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Bredent GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    visio.lign color: Characterization with colour effects on the surface of composite restorations, denture base materials and artificial denture teeth. visio.lign shield: Surface coating and wear resistance of composite restorations, denture base materials and artificial denture teeth.
    Device Description
    visio.lign shield & color is a light-curing, transparent or coloured, acrylate-based glossy coating. visio.lign color achieves colour effects on the surface of composite restorations, denture base materials and artificial denture teeth. visio.lign color is available in 17 shades. visio.lign shield provides a surface coating on composite restorations, denture base materials and artificial denture teeth. visio.lign shield is available in the thin-bodied version visio.lign shield LV and in the higher-viscosity version visio.lign shield HV.
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    K Number
    K152113
    Device Name
    BioHPP - breCAM.BioHPP
    Manufacturer
    Bredent GmbH & Co.KG
    Date Cleared
    2016-07-21

    (358 days)

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

    **Bredent GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering. - · Fully anatomical crowns and bridges (max. 2 pontics) - · Crown copings and bridge substructures for composite veneers (max. 2 pontics) - · Telescopic primary and secondary crowns and frameworks • Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques. Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection) Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section)) Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use "BioHPP elegance prefab for SKY" to fabricate an individual abutment.
    Device Description
    BioHPP is a tooth-colored thermoplastic high-performance polymer based on polyether ether ketone (PEEK), which was developed especially for the fabrication of dental restorations. Bio HPP is available in two different variations - as a granular material and prefabricated cylinders with diameters of 15 mm and 25 mm (so-called pellets). breCAM.BioHPP is based on filled polyether ether ketone (PEEK) and used for the fabrication of permanent crowns and bridges using CAD/CAM techniques. Three sizes are available.
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    K Number
    K101064
    Device Name
    BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
    Manufacturer
    BREDENT GMBH & CO.KG
    Date Cleared
    2010-09-14

    (151 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BREDENT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures. Permanent veneering: - telescopic and conical crowns - CoCr clasp restorations - crowns and bridges - implant-supported restorations - coverdenture techniques Veneer-up: - selection of esthetic shade, shape and tooth position Temporary restorations: - laboratory-made temporaries based on impression and wax-up - veneer on temporary abutments after placement of the implant The devices are offered in non-sterile condition.
    Device Description
    Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
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