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

    ACRYLIC IMPRESSION TRAY MATERIALS

    K Number: K873739 · Decision Mar 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    174

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    Basic Information

    Device Name
    ACRYLIC IMPRESSION TRAY MATERIALS
    K Number
    K873739
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3670
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    E&D Dental Manufacturing Co.
    Date Received
    September 15, 1987
    Decision Date
    March 7, 1988
    Product Code
    EBH
    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
    EBH Material, Impression Tray, Resin

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    Other Clearances by E&D Dental Manufacturing Co.

    K Number Device Name
    K883698 ZINC OXIDE EUGENOL TEMPORARY CEMENT
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    K864922 DENTAL HANDPIECES AND ATTACHMENT
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