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510(k) Data Aggregation

    K Number
    K081705
    Device Name
    LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2008-09-17

    (92 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN

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

    LANG DENTAL RESINCAP PATTERN AND COPING ACR YLIC RESIN is intended for the fabrication of patterns and copings.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a dental acrylic resin. It is a regulatory document and does not contain any information about acceptance criteria or a study proving device performance as requested. The letter confirms that the device, "Lang Dental Resincap Pattern and Coping Acrylic Resin," is substantially equivalent to legally marketed predicate devices for its intended use in "the fabrication of patterns and copings."

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or studies against acceptance criteria.

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