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

    DENTCA DENTURE Teeth

    K Number: K172398 · Decision Nov 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    DENTCA DENTURE Teeth
    K Number
    K172398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3590
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dentca, Inc.
    Date Received
    August 8, 2017
    Decision Date
    November 22, 2017
    Product Code
    PZY
    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
    PZY Additively Manufactured, Preformed, Resin Denture Tooth

    Other Clearances by Dentca, Inc.

    K Number Device Name
    K220042 Dentca Base Premium, Dentca Base Hi-Impact
    K192806 DENTCA Crown and Bridge
    K162044 Dentca Denture Base II
    K143033 DENTCA DENTURE BASE