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

    Amber Mill Q Series & Amber Mill Direct Series

    K Number: K202952 · Decision Aug 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    5
    Review Days
    330

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    Basic Information

    Device Name
    Amber Mill Q Series & Amber Mill Direct Series
    K Number
    K202952
    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
    September 30, 2020
    Decision Date
    August 26, 2021
    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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