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510(k) Data Aggregation

    K Number
    K983752
    Device Name
    ALUMINA-ZINC OXIDE POWDERS F AND R
    Manufacturer
    HARRY J. BOSWORTH CO.
    Date Cleared
    1998-12-10

    (48 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Alumina-Zinc Oxide Powders F and R are intended for use with a Eugenol and 2-Ethoxybenzoic Acid Liquid Mixture as a temporary or permanent cement, or as a base or liner in a dental restoration.

    Device Description

    Alumina-Zinc Oxide Powders F and R

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving the device meets those criteria. The text is a letter from the FDA to a medical device company regarding the clearance of their device, "Alumina-Zinc Oxide Powders F and R," through the 510(k) pathway. It confirms substantial equivalence to a predicate device and outlines regulatory responsibilities. It does not contain details about specific performance metrics, study designs, or results.

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