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

    DENTURE PRODUCT X

    K Number: K914257 · Decision Jan 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    129
    Same Product Code
    25
    Applicant Total
    15
    Review Days
    478

    Basic Information

    Device Name
    DENTURE PRODUCT X
    K Number
    K914257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3520
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Received
    September 23, 1991
    Decision Date
    January 13, 1993
    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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