BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EQUIA LC ONE

    K Number: K250953 · Decision Sep 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    127
    Review Days
    175

    Basic Information

    Device Name
    EQUIA LC ONE
    K Number
    K250953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GC America, Inc.
    Date Received
    March 28, 2025
    Decision Date
    September 19, 2025
    Product Code
    EMA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMA Cement, Dental

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.

    G-CEM UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    REGEN Bioactive Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    Bifix Veneer LC, Bifix Veneer Try-In

    FDA 510(k)
    FDA Class 2 ·Dental

    iCEM Universal Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    TopCEM Vigor SA Self-Adhesive Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    GlasIonomer FX-LC

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by GC America, Inc.

    K Number Device Name
    K261246 SRGC-06
    K254109 G-CEM UNIVERSAL
    K251124 G-Bond Universal
    K251946 G aenial Universal Injectable II
    K200798 G-CEM ONE
    K200682 BZF-29
    K192597 Cytrans Granules
    K193113 GC Temp Print
    K193484 GC Fuji Triage EP
    K192260 everX Flow
    Search all 127 clearances from GC America, Inc. →