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510(k) Data Aggregation

    K Number
    K142880
    Device Name
    DMRC Light Cure Orthodontic Adhesive System
    Manufacturer
    Daville Materials LLC
    Date Cleared
    2015-02-04

    (125 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DMRC Light Cure Orthodontic Adhesive System is a Light Cure Adhesive for bonding metal and ceramic brackets to tooth surfaces

    Device Description

    Not Found

    AI/ML Overview

    There is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is an FDA 510(k) clearance letter for a dental adhesive, which primarily discusses regulatory classification, general controls, and good manufacturing practices. It also includes the indications for use for the device. Clinical study details, performance metrics, and acceptance criteria are not part of this specific regulatory communication.

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