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510(k) Data Aggregation

    K Number
    K250953

    Validate with FDA (Live)

    Device Name
    EQUIA LC ONE
    Manufacturer
    GC America Inc.
    Date Cleared
    2025-09-19

    (175 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K172382,K993973,K130223
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Class I, II, III, IV and V restorations
    2. Root surface restoration
    3. Core build-up
    Device Description

    EQUIA LC ONE is a resin-modified glass ionomer dental restorative material which is intended to be used as a restorative filling material for direct restorations and or core buildups. The applicant device is provided as a powder/liquid formulation in a mixing capsule.

    AI/ML Overview

    N/A

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    K Number
    K091106

    Validate with FDA (Live)

    Device Name
    EQUIA
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2009-06-17

    (62 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K153174
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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