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

    MONOBLOC BM SERIES

    K Number: K111573 · Decision Aug 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    5
    Review Days
    81

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MONOBLOC BM SERIES
    K Number
    K111573
    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
    June 6, 2011
    Decision Date
    August 26, 2011
    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

    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    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
    View all

    Other Clearances by Hass Corp.

    K Number Device Name
    K260859 Rosetta SM, Rosetta SP
    K202952 Amber Mill Q Series & Amber Mill Direct Series
    K160102 Amber Mill Series and Amber Press Series
    K102305 HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P