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510(k) Data Aggregation

    K Number
    K111178
    Device Name
    JUELL SOFT CURE
    Manufacturer
    JUELL DENTAL
    Date Cleared
    2011-09-12

    (138 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K974772
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    JUELLCure Soft is intended for use as a permanent soft relining for total and partial dentures

    • . To relieve pressure from pressure points
    • To dam the palatal vibrating line ●
    • . In cases of flabby ridge and/or insufficient adhesion
    • . To cushion sharp-edged alveolar processes
    Device Description

    JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.

    AI/ML Overview

    The provided text describes the 510(k) summary for the JUELLCure Soft device, which is a soft impression material for dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel SC.

    Here's an analysis based on the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for JUELLCure Soft are based on demonstrating equivalence to the predicate device, Ufi Gel SC, across chemical composition and key physical properties.

    Test ItemAcceptance Criteria (Equivalent to Ufi Gel SC)JUELLCure Soft Performance
    Monomer Matrix (Base)70-80 %70-80 %
    Rheologic Modifier (Base)15-30 %15-30 %
    Catalyst (Base)0.1-0.5 %0.1-0.5 %
    Colorant (Base)
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