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510(k) Data Aggregation

    K Number
    K013674
    Device Name
    LUXATEMP/LUXATEMP SOLAR/INSTATEMP
    Manufacturer
    DMG USA, INC.
    Date Cleared
    2002-01-24

    (78 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K011211,K924830,K944981
    Why did this record match?
    Device Name :

    LUXATEMP/LUXATEMP SOLAR/INSTATEMP

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

    Luxatemp / InstaTemp are self-cure provisional crown and bridge composites for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.

    Luxatemp Solar is a dual-cure provisional crown and bridge composite for use in temporary crowns and bridges, long-term temporaries, inlays and onlays.

    Luxatemp / Luxatemp Solar / InstaTemp are also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

    Device Description

    Luxatemp / InstaTemp are self-cure bis-acrylic composite materials for use in the preparation of temporary crowns and bridges, inlays and onlays. Luxatemp Solar is a dual-cure bis-acrylic composite material for use in the preparation of temporary crowns and bridges, inlays and onlays Luxatemp / Luxatemp Solar / InstaTemp are also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or partial denture.

    AI/ML Overview

    This document is a 510(k) summary for a dental provisional material, not an AI/ML device study. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics is not applicable and cannot be extracted from this text.

    The closest relevant section is:

    Safety and Performance:
    "Substantial equivalence for this device was based on similarities in materials, design and performance characteristics. No safety or performance testing was required to establish substantial equivalence for Luxatemp / Luxatemp Solar / InstaTemp materials."

    This statement indicates that no new performance testing was conducted or required for this 510(k) submission because the device was considered substantially equivalent to already cleared predicate devices based on its materials, design, and performance characteristics.

    Therefore, I cannot provide the requested table or details about a study for acceptance criteria because such a study was not performed or referenced in this document.

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