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510(k) Data Aggregation

    K Number
    K973881
    Date Cleared
    1997-11-24

    (41 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins. It is perfect for Single Crown, Veneer Crowns, 3 to 4 crowns and short span bridges.

    Device Description

    Prospector Plus is a noble alloy under the Identalloy and ADA classification system for Dental Alloy. It is designed for Type-III hard Crown and Bridge alloy. Prospector Plus provides quality restorations. It is low gold containing alloy vet having rich brilliant gold color and it polishes to a higher luster. This noble alloy, free from Copper, makes it excellent tarnish resistant. Prospector Plus provides extremely accurate margins.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA to J.F. Jelenko & Company, Incorporated, regarding a dental alloy named "Prospector Plus." This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The letter is a regulatory approval, and while it indicates the device's intended use and classification, it does not delve into the specific performance metrics or clinical study results that would typically be detailed in a submission proving performance against acceptance criteria.

    Therefore, I cannot provide answers to the requested information based on the given text.

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