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

    RDT3 HANDPIECE HEAD MODEL RDT3

    K Number: K101172 · Decision Jul 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    92

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    Basic Information

    Device Name
    RDT3 HANDPIECE HEAD MODEL RDT3
    K Number
    K101172
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Redent Nova, Ltd.
    Date Received
    April 26, 2010
    Decision Date
    July 27, 2010
    Product Code
    EFA
    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
    EFA Handpiece, Belt And/Or Gear Driven, Dental

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