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

    DENTCA DENTURE BASE

    K Number: K143033 · Decision Jul 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    5
    Review Days
    272

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    Basic Information

    Device Name
    DENTCA DENTURE BASE
    K Number
    K143033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentca, Inc.
    Date Received
    October 22, 2014
    Decision Date
    July 21, 2015
    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 Dentca, Inc.

    K Number Device Name
    K220042 Dentca Base Premium, Dentca Base Hi-Impact
    K192806 DENTCA Crown and Bridge
    K172398 DENTCA DENTURE Teeth
    K162044 Dentca Denture Base II