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510(k) Data Aggregation

    K Number
    K151088
    Device Name
    DMRC Bulk Fill
    Manufacturer
    DANVILLE MATERIALS, LLC
    Date Cleared
    2015-08-28

    (127 days)

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

    DMRC Bulk Fill

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

    DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are use as the first incrual with posterior composites, for core build-ups; and for luting posts, crowns, veneers sead any application there light transmission may be inadequate

    Device Description

    DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives

    AI/ML Overview

    This document is a 510(k) premarket notification letter for a dental restorative material called "DMRC Bulk Fill." It focuses on the regulatory approval process and does not contain the kind of detailed clinical study information (acceptance criteria, device performance tables, sample sizes, expert qualifications, etc.) that you've requested regarding device performance and its proof.

    Therefore, I cannot extract the requested information from the provided text.

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