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510(k) Data Aggregation

    K Number
    K051999
    Device Name
    BISCOVER LED
    Manufacturer
    BISCO, INC.
    Date Cleared
    2005-08-22

    (28 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K043168
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface. BISCOVER LED is used to Seal and Polish: 1. Direct composites (cured) 2. Indirect composites 3. Provisionals 4. Acrylic appliances 5. Resin-modified Glass Ionomers 6. Enamel before or after orthodontic bracket placement 7. Etched Enamel

    Device Description

    BISCOVER LED is a low viscosity, light-cured resin formulation used to seal restorations and etched cnamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LED cures without any sticky oxygen-inhibited layer. BISCOVER LED may reduce or even eliminate the need for manual polishing. The photo-initiator used by BISCOVER LED allows most LD demal curing lights to achieve polymerization.

    AI/ML Overview

    The provided text describes a 510(k) summary for a dental device, BISCOVER LED, and its substantial equivalence to a predicate device, BISCOVER LV. It focuses on the chemical composition, intended use, and physical properties. However, it does not contain the kind of detailed performance study information with acceptance criteria, sample sizes, expert involvement, or statistical analysis typically found for AI/ML-based medical devices.

    Therefore, I cannot provide the requested information. The document is for a traditional dental material where performance is assessed through direct comparison of properties, not through studies involving ground truth, human readers, or AI performance metrics.

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