BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    PRODRIVE SYSTEMS REPLACEMENT TURBINE

    K Number: K062219 · Decision Aug 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    3
    Review Days
    2

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    Basic Information

    Device Name
    PRODRIVE SYSTEMS REPLACEMENT TURBINE
    K Number
    K062219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prodrive Systems, Inc.
    Date Received
    August 2, 2006
    Decision Date
    August 4, 2006
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Prodrive Systems, Inc.

    K Number Device Name
    K090369 PRODRIVE LINE OF DENTAL HANDPIECES
    K073353 DO-ALL DENTAL HANDPIECE LUBRICANT