BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS

    K Number: K071010 · Decision Aug 24, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    5
    Review Days
    137

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    Basic Information

    Device Name
    TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
    K Number
    K071010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schutz-Dental GmbH
    Date Received
    April 9, 2007
    Decision Date
    August 24, 2007
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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    K052073 FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
    K052189 REVENEER CERAMIC REPAIR SYSTEM
    K051050 SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092