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

    Concentrix MX-AC High-Speed Handpiece

    K Number: K173465 · Decision Mar 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    7
    Review Days
    140

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    Basic Information

    Device Name
    Concentrix MX-AC High-Speed Handpiece
    K Number
    K173465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalez, Inc.
    Date Received
    November 8, 2017
    Decision Date
    March 28, 2018
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Dentalez, Inc.

    K Number Device Name
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    K162397 Titan 3 Low Speed Angle Attachments
    K153411 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
    K113301 CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
    K093072 STARCARE HANDPIECE MAINTENANCE UNIT
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