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

    SRGC-06

    K Number: K261246 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    127
    Review Days
    63

    Basic Information

    Device Name
    SRGC-06
    K Number
    K261246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GC America, Inc.
    Date Received
    April 16, 2026
    Decision Date
    June 18, 2026
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

    Similar 510(k) Clearances

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

    DIAFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

    FDA 510(k)
    FDA Class 2 ·Dental

    Dual Core

    FDA 510(k)
    FDA Class 2 ·Dental

    Dura-Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    Grandio disc multicolor

    FDA 510(k)
    FDA Class 2 ·Dental

    Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

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

    Other Clearances by GC America, Inc.

    K Number Device Name
    K254109 G-CEM UNIVERSAL
    K251124 G-Bond Universal
    K250953 EQUIA LC ONE
    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. →