BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Rosetta SM, Rosetta SP

    K Number: K260859 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    5
    Review Days
    87

    Basic Information

    Device Name
    Rosetta SM, Rosetta SP
    K Number
    K260859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hass Corp.
    Date Received
    March 16, 2026
    Decision Date
    June 11, 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

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