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

    PROTEMP(R) GARANT

    K Number: K950203 · Decision Feb 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    17
    Review Days
    15

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    Basic Information

    Device Name
    PROTEMP(R) GARANT
    K Number
    K950203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Espe GmbH & Co. Kg.
    Date Received
    January 18, 1995
    Decision Date
    February 2, 1995
    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 Espe GmbH & Co. Kg.

    K Number Device Name
    K974231 POSITION PENTA, POSITION PENTA QUICK
    K973513 SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
    K973262 KETAC-FIL APLICAP PLUS
    K972892 CAVIT-LC
    K963735 COJET SYSTEM
    K963737 HYCEM APLICAP
    K962428 EBS (ESPE BONDING SYSTEM)
    K962442 HYTAC APLITIP/HYTAC OSB
    K962440 PERTAC II/PERTAC II APLITIP
    K960954 KETAC-MOLAR APLICAP
    Search all 17 clearances from Espe GmbH & Co. Kg. →