BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    DENTO-PREP PARTICLE MICROBLASTER

    K Number: K010816 · Decision May 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    47
    Applicant Total
    2
    Review Days
    52

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    Basic Information

    Device Name
    DENTO-PREP PARTICLE MICROBLASTER
    K Number
    K010816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6080
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ronvig A/S
    Date Received
    March 19, 2001
    Decision Date
    May 10, 2001
    Product Code
    KOJ
    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
    KOJ Airbrush

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