BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WILDE AUXILIARIES

    K Number: K912991 · Decision Dec 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    167
    Registration Numbers
    167
    Same Product Code
    322
    Applicant Total
    16
    Review Days
    164

    Basic Information

    Device Name
    WILDE AUXILIARIES
    K Number
    K912991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WILDE-USA, INC.
    Date Received
    July 8, 1991
    Decision Date
    December 19, 1991
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by WILDE-USA, INC.

    K Number Device Name
    K913582 COMPATIT R
    K915653 KERAMAIL
    K913581 WILDE ADHESIVE BONDING SYSTEM
    K923472 COMPACOLOR
    K920649 COMPASEP
    K913089 WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS
    K915250 WIL-PDS & WIL-PDI CASTING ALLOYS
    K912990 CONVERBASE
    K920557 WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX
    K915654 KERALLOY-D CAPS
    Search all 16 clearances from WILDE-USA, INC. →