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510(k) Data Aggregation

    K Number
    K011820
    Device Name
    DENTORIUM CONVERTIBLE ACRYLIC
    Manufacturer
    NATS CORP.
    Date Cleared
    2001-09-05

    (86 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DENTORIUM CONVERTIBLE ACRYLIC

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

    Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to provide a description of the acceptance criteria and study as the provided document is a 510(k) clearance letter for a dental device (Dentorium Convertible Acrylic) and does not contain information about acceptance criteria or supporting studies. It primarily states that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

    The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also includes an "Indications for Use" section (Page 2), which outlines what the device is intended for and its contraindications.

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

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