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

    OXY CUSTOM TRAY RESIN

    K Number: K801780 · Decision Aug 7, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    187
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    10

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    Basic Information

    Device Name
    OXY CUSTOM TRAY RESIN
    K Number
    K801780
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3670
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oxy Dental Products, Inc.
    Date Received
    July 28, 1980
    Decision Date
    August 7, 1980
    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 Oxy Dental Products, Inc.

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