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

    PRE-KLENE ENAMEL CLEANER

    K Number: K844572 · Decision Jan 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    127
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    PRE-KLENE ENAMEL CLEANER
    K Number
    K844572
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3520
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Medical Products Laboratories, Inc.
    Date Received
    November 23, 1984
    Decision Date
    January 18, 1985
    Product Code
    EFT
    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
    EFT Cleanser, Denture, Over The Counter

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