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

    SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER

    K Number: K973513 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    17
    Review Days
    96

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    Basic Information

    Device Name
    SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
    K Number
    K973513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Espe GmbH & Co. Kg.
    Date Received
    September 17, 1997
    Decision Date
    December 22, 1997
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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    Other Clearances by Espe GmbH & Co. Kg.

    K Number Device Name
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    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
    K960547 DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
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