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510(k) Data Aggregation

    K Number
    K260783

    Validate with FDA (Live)

    Device Name
    Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
    Manufacturer
    Kulzer, LLC
    Date Cleared
    2026-03-11

    (1 days)

    Product Code
    EBF,EBC,LBH
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K231817,K150128,K073554,K091635,K112501,K220605
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231817, K150128

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Venus Bulk Flow One

    • Class I, II, III, IV and V direct restorations
    • First-layer lining for class I and II cavities
    • Repair of direct and indirect restorations in combination with a suitable adhesive
    • Splinting of teeth
    • Extended fissure sealing
    • Composite attachments for aligner treatment
    • Fixation of retainers

    Venus Diamond Flow

    • Enlarged fissure sealing
    • Cavity lining – as the first layer for Class I and II cavities
    • Class I, II, III, IV and V direct restorations
    • Small repairs of direct and indirect restorations combined with a suitable bonding agent
    • Splinting of teeth
    • Composite attachments for aligner treatment
    • Fixation of retainers

    Venus Diamond

    • Direct restorations of all cavity classes
    • Direct composite veneers
    • Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)
    • Splinting of teeth
    • Restoration of primary teeth
    • Core build-up
    • Repairs of porcelain, composite (in combination with an adequate repair-system)
    • Composite attachments for aligner treatment
    • Fixation of retainers

    Venus Pearl

    • Direct restorations of all cavity classes
    • Direct composite veneers
    • Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)
    • Splinting of teeth
    • Restoration of primary teeth
    • Core build-up
    • Repairs of porcelain, composite (in combination with an adequate repair-system)
    • Composite attachments for aligner treatment
    • Fixation of retainers
    Device Description

    All four devices are light-curing, radiopaque, polymer-based dental composites (nano/nanohybrid) supplied in syringes and PLT units for professional use. They are applied in thin layers and polymerized using dental curing lights (typ. 450–480 nm; ~600–1550 mW/cm²). Packaging sizes and handling characteristics (viscosity/flow for the "Flow" and "Bulk Flow" variants; modeling characteristics for "Diamond" and "Pearl") align with their intended use in direct restorations and related clinical procedures, including aligner attachment fabrication and retainer fixation.

    Representative compositions include inorganic fillers (e.g., barium alumino-borosilicate glass, silica, ytterbium fluoride), dimethacrylate resins (e.g., UDMA, TEGDMA, TCD-urethaneacrylate, E4BADMA), initiators (e.g., camphorquinone), stabilizers (e.g., BHT), and pigments/fluorescent agents. Radiopacity meets ISO 4049 acceptance criteria and is within the enamel/dentin-relevant ranges reported for each product.

    AI/ML Overview

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