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

    DENTRON-DIRECT-TRAY

    K Number: K820998 · Decision Jun 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    DENTRON-DIRECT-TRAY
    K Number
    K820998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3670
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dentron, Inc.
    Date Received
    April 9, 1982
    Decision Date
    June 10, 1982
    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 Dentron, Inc.

    K Number Device Name
    K820997 DENTRON-EXACT - TRAY