BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BELMONT QUOLIS 5000 SERIES DENTAL UNIT

    K Number: K072273 · Decision Dec 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    BELMONT QUOLIS 5000 SERIES DENTAL UNIT
    K Number
    K072273
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Takara Belmont USA, Inc.
    Date Received
    August 15, 2007
    Decision Date
    December 20, 2007
    Product Code
    NRD
    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
    NRD Unit, Operative Dental, Accessories

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    ACCLAIM

    FDA 510(k)
    FDA Class 1 ·Dental
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