BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRISMA-FIL COMPULES

    K Number: K812277 · Decision Sep 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    PRISMA-FIL COMPULES
    K Number
    K812277
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Caulk Co., Div. Dentsply
    Date Received
    August 13, 1981
    Decision Date
    September 8, 1981
    Product Code
    EID
    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
    EID Syringe, Restorative And Impression Material

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    Other Clearances by Caulk Co., Div. Dentsply

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