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510(k) Data Aggregation

    K Number
    K013375
    Device Name
    BELLEGLASS HP OPAQUE 2
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Date Cleared
    2001-10-29

    (18 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BELLEGLASS HP OPAQUE 2

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

    BelleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.

    Device Description

    belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations. belleGlass HP Opaque 2 is also used with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

    AI/ML Overview

    This document is a 510(k) Summary for the BelleGlass HP Opaque 2, a dental material. It does not contain information about acceptance criteria or a study proving device performance as it is a premarket notification for a dental material, not an AI/ML powered device. Therefore, I cannot provide the requested information based on the provided text.

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