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

    IMPRESSION MATERIAL, ALGINATE

    K Number: K770872 · Decision Jun 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    59
    Review Days
    19

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    Basic Information

    Device Name
    IMPRESSION MATERIAL, ALGINATE
    K Number
    K770872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3580
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Espe GmbH (Us)
    Date Received
    May 13, 1977
    Decision Date
    June 1, 1977
    Product Code
    ELN
    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
    ELN Teeth, Preformed Gold Denture

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    K904096 PHOTAC-BOND
    K904097 PHOTAC-BOND APLICAP
    K904289 PERTAC UNIVERSAL BOND
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