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

    TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

    K Number: K133268 · Decision Feb 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    5
    Review Days
    476

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    Basic Information

    Device Name
    TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
    K Number
    K133268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Schutz-Dental GmbH
    Date Received
    October 24, 2013
    Decision Date
    February 12, 2015
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Schutz-Dental GmbH

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    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