BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR

    K Number: K991996 · Decision Sep 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
    K Number
    K991996
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Denplus, Inc.
    Date Received
    June 14, 1999
    Decision Date
    September 8, 1999
    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 Denplus, Inc.

    K Number Device Name
    K011762 HI-WAVE; POUR-PLUS