BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    EVO 450 series High Speed Handpieces

    K Number: K190508 · Decision Dec 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    6
    Review Days
    285

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    Basic Information

    Device Name
    EVO 450 series High Speed Handpieces
    K Number
    K190508
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ttbio Corp.
    Date Received
    March 1, 2019
    Decision Date
    December 11, 2019
    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 Ttbio Corp.

    K Number Device Name
    K232243 EVO 700 series high speed handpiece
    K210832 EVOCLEAN CLEANsert Ultrasonic Insert
    K201317 TTBIO EVOCLEAN Ultrasonic Scaler
    K141183 EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
    K132570 ELECTRIC HANDPIECE SYSTEM