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

    STARCARE HANDPIECE MAINTENANCE UNIT

    K Number: K093072 · Decision Dec 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    7
    Review Days
    89

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    Basic Information

    Device Name
    STARCARE HANDPIECE MAINTENANCE UNIT
    K Number
    K093072
    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
    September 30, 2009
    Decision Date
    December 28, 2009
    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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    K173465 Concentrix MX-AC High-Speed Handpiece
    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
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