BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.

    K Number: K844446 · Decision Oct 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    6
    Review Days
    347

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    Basic Information

    Device Name
    BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.
    K Number
    K844446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Pulpdent Corp. of America
    Date Received
    November 16, 1984
    Decision Date
    October 29, 1985
    Product Code
    ELW
    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
    ELW Material, Impression

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