BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray

    K Number: K150750 · Decision Jul 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    42
    Review Days
    101

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
    K Number
    K150750
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sirona Dental Systems GmbH
    Date Received
    March 23, 2015
    Decision Date
    July 2, 2015
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EGS), ordered by most recent decision date.

    Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

    FDA 510(k)
    FDA Class 1 ·Dental

    Disposable Prophy Angle

    FDA 510(k)
    FDA Class 1 ·Dental

    Star E900 Handpiece Series

    FDA 510(k)
    FDA Class 1 ·Dental

    General Cutting Straight

    FDA 510(k)
    FDA Class 1 ·Dental

    FX Contra

    FDA 510(k)
    FDA Class 1 ·Dental

    Smooth Drive contra angle and straight handpieces

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Sirona Dental Systems GmbH

    K Number Device Name
    K160099 CEREC SpeedGlaze
    K151045 TENEO Dental Treatment Unit and Accessories
    K150909 INTEGO Family and Accesories
    K150217 ORTHOPHOS SL
    K131319 T1/T2/T3 TURBINE FAMILY
    K132773 SIDEXIS 4
    K123664 INCORIS ZI
    K123952 CEREC BLOCS C IN
    K123070 GALILEOS FAMILY
    K123545 INCORIS TZI
    Search all 42 clearances from Sirona Dental Systems GmbH →