BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    K Number: K260370 · Decision Mar 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    2
    Review Days
    53

    Basic Information

    Device Name
    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    K Number
    K260370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bloomden Bioceramics (HuNan) Co., Ltd.
    Date Received
    February 5, 2026
    Decision Date
    March 30, 2026
    Product Code
    EIH
    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
    EIH Powder, Porcelain

    Similar 510(k) Clearances

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

    Rosetta SM, Rosetta SP

    FDA 510(k)
    FDA Class 2 ·Dental

    DCMhotbond zircon

    FDA 510(k)
    FDA Class 2 ·Dental

    Eternal Art Porcelain Powders

    FDA 510(k)
    FDA Class 2 ·Dental

    IPS e.max Zirconia

    FDA 510(k)
    FDA Class 2 ·Dental

    BruxZir® Shaded 16 PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

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

    Other Clearances by Bloomden Bioceramics (HuNan) Co., Ltd.

    K Number Device Name
    K212765 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank