BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    EVOCLEAN CLEANsert Ultrasonic Insert

    K Number: K210832 · Decision Feb 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    6
    Review Days
    320

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    Basic Information

    Device Name
    EVOCLEAN CLEANsert Ultrasonic Insert
    K Number
    K210832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ttbio Corp.
    Date Received
    March 19, 2021
    Decision Date
    February 2, 2022
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by Ttbio Corp.

    K Number Device Name
    K232243 EVO 700 series high speed handpiece
    K201317 TTBIO EVOCLEAN Ultrasonic Scaler
    K190508 EVO 450 series High Speed Handpieces
    K141183 EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
    K132570 ELECTRIC HANDPIECE SYSTEM