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510(k) Data Aggregation

    K Number
    K980963
    Device Name
    HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1998-05-11

    (56 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)

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

    Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.

    Device Description

    polysiloxane impression materials

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not describe any acceptance criteria or a study proving that a device meets such criteria. It's a regulatory approval document confirming substantial equivalence to a predicate device, not a technical performance report.

    Therefore, I cannot extract the requested information from this document.

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