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510(k) Data Aggregation

    K Number
    K111177
    Device Name
    JUELL HARD 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
    K030916
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures. Hard permanent total or partial relining for restoring partial and complete dentures. Lengthening denture margins.

    Device Description

    JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.

    AI/ML Overview

    The provided text describes the 510(k) summary for the JuellCure Hard, a hard impression material for relining dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel Hard C (K030916).

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Predicate Device K030916)Reported Device Performance (JuellCure Hard)
    Setting Time135-180 seconds135-180 seconds
    AppearancePaste is a colorless, homogenous liquid and the catalyst is a white homogenous paste.Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste.
    Composition of CatalystMatrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer
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