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510(k) Data Aggregation

    K Number
    K052780
    Device Name
    DENTAPLAST HOT, MODEL 16-XXX
    Manufacturer
    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
    Date Cleared
    2005-12-21

    (79 days)

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

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.
    Device Description
    Dentaplast hot is a polymerizing denture resin on the basis of methylmetacrylate. Dentaplast hot allows to obtain extended processing time and offers fine flowability and is therefore matched with the Dentaplast hot casting sstem. The catalyst is free from tertiary amine and ensures high colour stability. Dentaplast is entirely cadmium-free. Application range: -Fabrication of full dentures in the resin casting technique -Completion of CoCr dentures -Relinings and shaping of functional margins -any type of repair work such as cracks, fractures.
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    K Number
    K052779
    Device Name
    BRECOMP
    Manufacturer
    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
    Date Cleared
    2005-12-20

    (78 days)

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

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brecomp is intended to restore carious lesions or structural defects in teeth.
    Device Description
    Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049. Application range: Universal dental restorative material for the following indications: - cavity classes I to V - inlays, veneers (direct and indirect) - crown suprastructures - post and core buildups
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    K Number
    K052781
    Device Name
    BREFORMANCE
    Manufacturer
    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
    Date Cleared
    2005-12-09

    (67 days)

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

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
    Device Description
    breformance ColdCuringPolymer is a C+B material for temporary restorations
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