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510(k) Data Aggregation

    K Number
    K984140
    Device Name
    MAINBOND A
    Manufacturer
    J.F. JELENKO & CO., INC.
    Date Cleared
    1999-01-13

    (56 days)

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

    Maintbonc. A is a high noble alloy under Identalloy and ADA classification system for Dental alloy. It is designed for porcelain, application and compatible with low fusing porcelains in the market. Mainbond A is a rich yellow color, palladium free alloy and it provides quality restoration. It can also be used as Type-IV crown and bridge alloy. It polishes to a high luster and can be used for Single, 3 to 4 crowns.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a dental alloy named "Mainbond A". It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

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